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Survodutide

  • Peptide
  • Still being tested
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Survodutide does in the body

Studied for obesity and fatty liver disease, but not yet approved.

One half of the molecule is a familiar appetite signal that makes you eat less. The other half switches on glucagon, the hormone that tells the liver to release and burn stored fuel. Together they are meant to work on both sides of the energy balance. The liver arm is also why this drug has a fatty-liver programme that most of its competitors do not.

What happened in people

In a 387-person study, the highest-dose group lost about 15% of body weight on average, versus about 3% with a dummy treatment.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

Only 60% completed the weight study, and improvement in liver scarring was less clear.

Where it acts
Hepatocyte, hypothalamus, pancreatic islet, adipose tissue
Kind of result
A number that stands in for health
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · 2ALA66NS64 · read 2026-08-29

  • Its recorded molecular formula is C192H289N47O61, weighing 4232.

    PubChem record · 171378821 · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 100 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 9 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Body weightNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
hba1c from baseline to 16 weeks
Body weight
body weight from baseline to week 52

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
1 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Percentage change in body weight at week 46

The study showed what it set out to show

Who was studied
Phase 2 obesity dose-finding (NCT04667377)
How many people
387
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Dose-dependent separation from placebo across all doses
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Only 60.4% of treated participants completed the 46-week treatment period, which limits what the mean change describes

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous once-weekly injection, investigational

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Percentage change in body weight and at least 5% reduction at week 76

The study showed what it set out to show

Who was studied
SYNCHRONIZE-1 (NCT06066515)
How many people
725
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
P < 0.001 for all comparisons with placebo
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Gastrointestinal symptoms in 80.9% and 89.7% of the treated groups versus 47.9% on placebo

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous once-weekly injection, investigational

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Histological improvement in MASH with no worsening of fibrosis at week 48

The study showed what it set out to show

Who was studied
Phase 2 MASH biopsy trial (NCT04771273)
How many people
293
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
P < 0.001 for the quadratic dose-response model
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Vomiting in 41% versus 4% on placebo

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous once-weekly injection, investigational

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Cardiovascular safety

The study showed what it set out to show

Who was studied
SYNCHRONIZE-CVOT (NCT06077864)
How many people
5531
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Listed as completed; results not yet in the peer-reviewed record at this audit
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous once-weekly injection, investigational

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.4 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Survodutide

    What a person takes: Subcutaneous once-weekly injection, investigational.

    The measurement behind this step

    Weekly subcutaneous dosing with a long stepwise escalation, at maintenance doses of 3.6 mg and 6.0 mg in the phase 3 obesity trial. No licensed presentation exists.

  2. Getting in

    Weekly subcutaneous injection with a long dose escalation

    One injection a week, built up gradually over months because the gastrointestinal effects are severe if the dose rises quickly.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    An acylated dual agonist peptide with a half-life supporting weekly dosing. The phase 3 protocol allowed a prolonged escalation period, which the primary estimand explicitly accounts for.

  3. Reaching the cell

    Two receptors with opposite effects on glucose

    GLP-1 lowers blood sugar. Glucagon raises it. The molecule is tuned so the first outweighs the second.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Balanced agonism at GLP-1R and GCGR, both Gs-coupled. The potency ratio is the central design parameter, because unopposed glucagon receptor agonism raises hepatic glucose output.

  4. What it acts on

    GLP-1 arm: appetite and insulin

    The appetite side does what every drug in this class does, reducing intake and slowing the stomach.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Central GLP-1R signalling in the hypothalamus and hindbrain reduces energy intake; peripheral signalling potentiates glucose-stimulated insulin secretion.

  5. The change it makes

    Glucagon arm: the liver empties its fat

    The glucagon side tells the liver to burn and export stored fat, which is why the liver-biopsy results are the most interesting part of this programme.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Hepatic GCGR agonism raises fatty acid oxidation, reduces de novo lipogenesis and increases energy expenditure. Preclinical work with hepatocyte-specific GCGR deletion indicates the hepatic receptor is required for the superior metabolic effect.

  6. What that does for a person

    Weight down 13%, steatohepatitis improved in 62%

    In the pivotal obesity trial, 13.0% weight loss against 5.4% on placebo. In the liver trial, disease improvement on a second biopsy in 62% against 14%.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    SYNCHRONIZE-1 treatment-regimen estimand -13.0% at week 76; phase 2 MASH histological improvement without worsening fibrosis in 62% at the 4.8 mg dose versus 14% on placebo.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • hba1c from baseline to 16 weeks
  • body weight from baseline to week 52
  • maximum measured concentration of midazolam in plasma
  • maximum measured concentration of the analyte in plasma

Meaningful

Things that change how a life goes, not only a number.

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (5)
  • drug related adverse events
  • treatment emergent adverse events
  • auc0 168
  • auc0 tz
  • cmax

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Trial participants with obesity, or with biopsy-confirmed steatohepatitis and fibrosis stage F1 to F3.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

Where the result stopped carrying

  • Glucagon-containing co-agonists as a class were held back by glucagon-driven hyperglycaemia, which the potency ratio in this molecule is engineered around
  • Tolerability at the highest phase 2 dose, where four in ten participants left before the end
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Still being tested

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Subcutaneous once-weekly injection, investigational

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

The identity record classes it as investigational; no register records an approval.

No source is stored against this line.

What is in the pack

0 mg in the phase 3 obesity trial. No licensed presentation exists.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Gastrointestinal events dominate and are more frequent than with selective GLP-1 agonists: nausea 66% and vomiting 41% in the liver trial, and gastrointestinal symptoms in up to 89.7% of the phase 3 obesity groups. No deaths were reported in SYNCHRONIZE-1. Long-term safety is not established.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearNothing found in the sources checked

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Subcutaneous once-weekly injection, investigational

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

0 mg in the phase 3 obesity trial. No licensed presentation exists.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine, investigational agent. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Survodutide studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That the 14.9% phase 2 figure is the effect size of this drug; the pivotal trial reported 13.0% against a 5.4% placebo response

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That it reverses fibrosis; the fibrosis endpoint was secondary and the placebo arm reached 22%

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That a completed cardiovascular safety trial demonstrates cardiovascular benefit

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

How fast does the body clear it?

The sources RNAWiki checked hold nothing for this field.

Why it matters. Without this, nothing on this page can say how long anything lasts.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

Phase 2 obesity: 14.9% weight loss at 46 weeks on the top dose
In plain words
In 387 adults, weight fell 14.9% on the 4.8 mg dose against 2.8% on placebo. Only 60% of participants completed the 46 weeks.
What was measured
Mean percentage change in body weight at week 46
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Dose-finding phase 2 across 43 centres in 12 countries. Mean weight change from baseline to week 46: -6.2% (0.6 mg), -12.5% (2.4 mg), -13.2% (3.6 mg), -14.9% (4.8 mg), -2.8% (placebo). 233 of 386 treated participants (60.4%) completed. Adverse events in 91% on survodutide versus 75% on placebo, primarily gastrointestinal in 75% versus 42%.
Source
le Roux CW et al. Lancet Diabetes Endocrinol 2024;12:162-173 (NCT04667377)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Phase 3 delivered 13.0%, and the placebo arm lost 5.4%
In plain words
The pivotal trial in 725 people gave 12.2% and 13.0% weight loss for the two doses. Placebo lost 5.4%. The gap over placebo shrank from about 12 points in phase 2 to about 7.6 in phase 3.
What was measured
Percentage change in body weight at week 76 under the treatment-regimen estimand
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SYNCHRONIZE-1, phase 3, double-blind, 76 weeks. Treatment-regimen estimand mean weight change -12.2% (95% CI -13.6 to -10.8) on 3.6 mg, -13.0% (95% CI -14.4 to -11.6) on 6.0 mg, and -5.4% (95% CI -6.9 to -4.0) on placebo. Weight reduction of at least 5% in 72.6%, 71.9% and 46.3%. The estimand incorporates early discontinuation, use of prohibited obesity medications and prolonged escalation, which is a more conservative analysis than the phase 2 reporting.
Source
Survodutide Once Weekly for the Treatment of Adults with Obesity. NEJM 2026 (NCT06066515)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Phase 2 steatohepatitis: 62% histological improvement against 14% on placebo
In plain words
In 293 people with biopsy-confirmed fatty liver inflammation, the middle dose improved the disease on a second biopsy in 62% of participants, against 14% on placebo.
What was measured
Histological improvement in MASH without worsening of fibrosis at week 48
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
48-week phase 2, biopsy-confirmed MASH with fibrosis F1 to F3, four arms. Improvement in MASH without worsening of fibrosis in 47% (2.4 mg), 62% (4.8 mg) and 43% (6.0 mg) versus 14% placebo, P<0.001 for the quadratic dose-response model. Fibrosis improvement by at least one stage in 34%, 36%, 34% and 22%. Nausea 66% versus 23%, vomiting 41% versus 4%.
Source
Sanyal AJ et al. N Engl J Med 2024;391:311-319 (NCT04771273)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
That the fibrosis result is as strong as the steatohepatitis result
In plain words
The inflammation endpoint separated clearly from placebo. Fibrosis improvement was 34 to 36% on treatment against 22% on placebo, a much narrower gap, and fibrosis is the part that predicts outcomes.
What was measured
At least one-stage fibrosis improvement, 34 to 36% versus 22%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Improvement in fibrosis by at least one stage was a secondary endpoint at 34%, 36% and 34% versus 22% on placebo. The trial was powered for the primary histological endpoint, not for fibrosis, and phase 2 histology in liver disease has a documented history of not reproducing at phase 3 scale.
Source
Sanyal AJ et al. N Engl J Med 2024;391:311-319
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Tolerability is the constraint, and it shows up in the completion rates
In plain words
Four in ten phase 2 participants did not finish. In phase 3, gastrointestinal side effects affected 81% to 90% of the treated groups against 48% on placebo.
What was measured
Trial completion and gastrointestinal adverse event rates
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Phase 2: 60.4% completed the 46-week treatment period, with gastrointestinal adverse events in 75% of survodutide recipients. Phase 3 SYNCHRONIZE-1: gastrointestinal symptoms in 80.9% of the 3.6 mg group and 89.7% of the 6.0 mg group versus 47.9% on placebo. No deaths were reported in phase 3.
Source
le Roux CW et al. Lancet Diabetes Endocrinol 2024; SYNCHRONIZE-1, NEJM 2026
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
That the cardiovascular safety trial has answered the outcome question
In plain words
SYNCHRONIZE-CVOT enrolled 5,531 people and is listed as completed. It is a cardiovascular safety trial, which is a different question from whether the drug prevents heart attacks.
What was measured
That survodutide reduces cardiovascular events
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
NCT06077864 is described as a study to test the effect of survodutide on cardiovascular safety, phase 3, enrolment 5,531, status COMPLETED. A safety trial is designed to exclude harm above a margin, not to demonstrate benefit; treating a met safety endpoint as evidence of cardiovascular protection is a category error.
Source
ClinicalTrials.gov record NCT06077864 (SYNCHRONIZE-CVOT)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

FDA substance identifier (UNII)
2ALA66NS64
CAS registry number
2805997-46-8
WHO international nonproprietary name list entry
12491
EMA substance identifier
300000026812

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A dual glucagon and GLP-1 receptor agonist whose phase 3 obesity trial produced 13.0% weight loss against 5.4% on placebo at 76 weeks, and whose phase 2 liver-biopsy trial improved steatohepatitis in 62% of participants against 14% on placebo.

Recorded evidence blocks (9)

What did Survodutide's largest trial (5531 people) and its longest (7.2 years) measure?


5531 people in Survodutide's largest registered study, 7.2 years in its longest registered window, measuring Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s),… ClinicalTrials.gov · 2026-09-01

19 phase1, 9 phase3, 4 phase2; NCT06632444; 2031-12-27; no ageing endpoint recorded. Last human test completed 2026, NCT07221591.

Interpretation These counts include studies where Survodutide was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase1
    19
  • phase3
    9
  • phase2
    4
  • Last recorded human test NCT07221591
    2026-07-28

recorded 2026-09-01 · last checked 2026-09-04

Survodutide was tested only in human — what did it show?


human: lifespan (32): the rungs where Survodutide has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant,… — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human lifespan
Show the evidence
  • human NCT06632444
    lifespan; Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to…; 32

recorded 2026-09-01 · last checked 2026-09-04

Could one person measure Survodutide's effect on drug related adverse events?


Drug related adverse events: measured in Survodutide's trials.

Interpretation drug related adverse events is the recorded endpoint.

Show the evidence

biomarkers

  • drug related adverse events; 2026-09-01
  • hba1c from baseline to 16 weeks; 2026-09-01
  • treatment emergent adverse events; 2026-09-01
  • body weight from baseline to week 52; 2026-09-01
  • auc0 168; 2026-09-01
  • maximum measured concentration of midazolam in plasma; 2026-09-01
3 more recorded rows
  • biomarkers
    maximum measured concentration of the analyte in plasma; 2026-09-01
  • biomarkers
    auc0 tz; 2026-09-01
  • biomarkers
    cmax; 2026-09-01
  • human trials at or under30
    7
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    6; NCT05421338; PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED

Which of auc0 168, auc0 tz and body weight from baseline to week 52 did Survodutide's trials measure?


auc0 168, auc0 tz and body weight from baseline to week 52 lead 9 outcome terms across Survodutide's trials. ClinicalTrials.gov · 2026-09-01

body weight from baseline to week 52, auc0 168, maximum measured concentration of midazolam in plasma, maximum measured concentration of the analyte in plasma, auc0 tz and cmax follow.

Show the evidence
  • drug related adverse events
    1
  • hba1c from baseline to 16 weeks
    1
  • treatment emergent adverse events
    1
  • body weight from baseline to week 52
    1
  • auc0 168
    1
  • maximum measured concentration of midazolam in plasma
    1
3 more recorded rows
  • maximum measured concentration of the analyte in plasma
    1
  • auc0 tz
    1
  • cmax
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Survodutide's 7 ongoing trials reports first?


7 registered trials of Survodutide are open; earliest completion 2026-12-22. ClinicalTrials.gov · 2026-09-01

Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit; Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score; latest 2031-12-27

Show the evidence

Trial

  • NCT05202353
    "A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver"; n 29; "Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit"; 2027-01-15
  • NCT06632444
    "LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis"; n 1800; "Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score"; 2031-12-27
  • NCT06632457
    "LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis"; n 1590; "Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH"; 2029-06-05
  • NCT06745284
    "A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity"; n 64; "Absolute change in sleeping metabolic rate (SMR) (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss"; 2027-01-10
  • NCT07206290
    "Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease"; n 120; "Change in first morning void UACR"; 2027-11-30
  • NCT07754461
    "A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar"; n 600; "Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41"; 2028-05-01
  • 1 further recorded trial NCT07768813
    "A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity"; n 44; "Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)"; 2026-12-22

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Survodutide could settle lifespan?


NCT06632457 measures Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH, reading out 2029-06-05.

1 open trial; n 1590; "LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis"

Show the evidence
  • Trial NCT06632457
    "LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis"; n 1590; "Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH"; 2029-06-05

Which 6 trials of Survodutide posted no result?


Posted no result
6 of 6 completed trials
Registrations
NCT03175211, NCT03591718, NCT04384081, NCT05421338, NCT05296733 and NCT05751226
Completion dates
oldest 2018-02-19; newest 2024-08-01
Show the evidence

Trial

  • NCT03175211
    2018-02-19
  • NCT03591718
    2020-04-30
  • NCT04384081
    2021-01-20
  • NCT05421338
    2022-11-17
  • NCT05296733
    2023-12-29
  • NCT05751226
    2024-08-01

At the median, Survodutide's trials enrolled 94 people — anything larger?


Median enrolment
94
Largest enrolment
5531
Registered trials counted
32

Was Survodutide studied with fasting?


fasting is named in Survodutide's label sentences: "In trial 1404-0002, survodutide was associated with significant and rapid increases in HOMA-β versus placebo, with significant decreases in HOMA-IR, glucagon, and fasting plasma glucose (FPG)." openfda-label+europepmc · 2026-06-22

1 recorded statement; fasting

Show the evidence
  • fasting
    In trial 1404-0002, survodutide was associated with significant and rapid increases in HOMA-β versus placebo, with significant decreases in HOMA-IR, glucagon, and fasting plasma glucose (FPG).

recorded 2026-06-22 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL5314776
CAS number
2805997-46-8
Development code
BI 456906, BI456906
Also called
Survodutida, L-Alaninamide, L-histidyl-1-aminocyclobutanecarbonyl-L-glutaminylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-tyrosyl-L-seryl-L-lysyl-L-tyrosyl-L-leucyl-L-α-aspartyl-L-α-glutamyl-L-arginyl-L-alanyl-L-alanyl-L-lysyl-L-α-aspartyl-L-phenylalanyl-L-isoleucyl-N6-[N-(17-carboxy-1-oxoheptadecyl)-L-γ-glutamylglycyl-L-serylglycyl-L-serylglycylglycyl]-L-lysyl-L-tryptophyl-L-leucyl-L-α-glutamyl-L-seryl-, L-Histidyl-1-aminocyclobutanecarbonyl-L-glutaminylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-tyrosyl-L-seryl-L-lysyl-L-tyrosyl-L-leucyl-L-α-aspartyl-L-α-glutamyl-L-arginyl-L-alanyl-L-alanyl-L-lysyl-L-α-aspartyl-L-phenylalanyl-L-isoleucyl-N6-[N-(17-carboxy-1-oxoheptadecyl)-L-γ-glutamylglycyl-L-serylglycyl-L-serylglycylglycyl]-L-lysyl-L-tryptophyl-L-leucyl-L-α-glutamyl-L-seryl-L-alaninamide, SURVODUTIDE [USAN], Survodutide [WHO-DD], survodutide [INN]
Sources (5)

Sources

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

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