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ENLICITIDE DECANOATE

  • Prescription medicine
  • Prescription only
  • 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 ENLICITIDE DECANOATE does in the body

Low-density lipoprotein cholesterol

From the FDA-approved label: Enlicitide is a macrocyclic peptide that binds to PCSK9. PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, enlicitide increases the number of LDLRs available to clear LDL-C, thereby lowering LDL-C levels.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · PSR59MCX5M · read 2026-08-29

  • Its recorded molecular formula is C92H129FN14O17, weighing 1722.12 g/mol.

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-30

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 71 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.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

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 20 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
CholesterolNothing 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 moved2 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
Cholesterol
low density lipoprotein cholesterol at week 24; low density lipoprotein cholesterol at day 56

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
2 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.

Blinded Period: Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus

The study did not show it

Who was studied
NCT06008756
How many people
14550
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Number of participants with one or more adverse events (AEs)

The study did not show it

Who was studied
NCT06492291
How many people
3000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

The study did not show it

Who was studied
NCT05952856
How many people
2912
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)

The study did not show it

Who was studied
NCT07216482
How many people
975
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8

The study did not show it

Who was studied
NCT07614984
How many people
750
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

The study did not show it

Who was studied
NCT05952869
How many people
303
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  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.10 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 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.

  • low density lipoprotein cholesterol at week 24
  • low density lipoprotein cholesterol at day 56
  • maximum plasma concentration of enlicitide in plasma
  • maximum plasma concentration of levothyroxine
  • time to maximum plasma concentration of levothyroxine
  • maximum plasma concentration of triiodothyronine
  • time to maximum plasma concentration of triiodothyronine
  • maximum plasma concentration of warfarin
  • time to maximum plasma concentration of warfarin
  • maximum plasma concentration of lisinopril

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 (10)
  • one or more adverse events
  • who discontinued study drug due to an ae
  • adverse events
  • who discontinue study drug due to an ae
  • who experience one or more adverse events
  • who discontinue study intervention due to an ae
  • apparent terminal half life of warfarin
  • apparent clearance of warfarin
  • who experience an adverse event
  • who discontinue study treatment due to an ae

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.

  • LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

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.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of LIPFENDRA have not been established in pediatric patients.”

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-30

  • On older people, the label states: “Of the 2,137 patients treated with LIPFENDRA in placebo-controlled trials, 960 (45%) patients were 65 years of age and older, and 252 (12%) patients were 75 years of age and older.”

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Discontinue LIPFENDRA when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.”

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information on the presence of enlicitide in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-30

Where the result stopped carrying

  • 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.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 3 related forms. Evidence does not carry across all of them.

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 (9)
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

Prescription only

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

Oral

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

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

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

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, given by the oral route.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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 unclearRead from sources, not yet reviewed

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

Oral

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.

    FDA National Drug Code directory · 0006-5084 · read 2026-08-29

  • They are sold as powder and tablet, film coated, taken oral.

    FDA National Drug Code directory · 0006-5084 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-29

  • 5 marketed supplement labels list this ingredient, classed as amino acid/protein, non-nutrient/non-botanical and other combinations.

    NIH Dietary Supplement Label Database · 277783 · read 2026-08-29

  • Those labels carry all other and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 277783 · read 2026-08-29

  • LIPFENDRA is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 20 mg enlicitide, white to off-white with grey specks, oval-shaped, film-coated, debossed with “119” on one side and the corporate logo on the other side Film-Coated Tablets: 20 mg…, recorded as fda label in effect 2026-07-15 in the United States.

    US prescribing information · 100ec543-fbd0-44fc-b740-db9cdff39145 · read 2026-08-30

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

Names and forms linked to this record

  • Contains

    Capric Acid

    Evidence on this page does not automatically apply to this one.

  • Contains

    Enlicitide

    Evidence on this page does not automatically apply to this one.

  • Ester of

    Enlicitide

    Evidence on this page does not automatically apply to this one.

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.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of ENLICITIDE DECANOATE 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

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.

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.

Formulation uncertainty

Several salts, forms or products of ENLICITIDE DECANOATE are recorded. Results from one form may not transfer to another.

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.

Where else this substance is registered

FDA substance identifier (UNII)
PSR59MCX5M
CAS registry number
2861205-06-1
EMA substance identifier
300000054311

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was NDA220848, approved 20260715 to MSD.

    Drugs@FDA application register · NDA220848 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA220848 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20260211.

    FDA National Drug Code directory · 0006-5084 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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Recorded evidence blocks (7)

What did ENLICITIDE DECANOATE's largest trial (14550 people) and its longest (11 years) measure?


14550 people in ENLICITIDE DECANOATE's largest registered study, 11 years in its longest registered window, measuring Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate. ClinicalTrials.gov · 2026-09-01

17 phase1, 7 phase3, 2 phase2; NCT07058077; 2037-01-23; no ageing endpoint recorded. Last human test completed 2025, NCT07044479.

Interpretation These counts include studies where ENLICITIDE DECANOATE 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
    17
  • phase3
    7
  • phase2
    2
  • Last recorded human test NCT07044479
    2025-08-28

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

ENLICITIDE DECANOATE was tested only in human — what did it show?


human: biomarker (25): the rungs where ENLICITIDE DECANOATE has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT05934292
    biomarker; Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate; 25

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

Could one person measure ENLICITIDE DECANOATE's effect on low density lipoprotein cholesterol at week 24?


Low density lipoprotein cholesterol at week 24: measured in ENLICITIDE DECANOATE's trials.

low density lipoprotein cholesterol at week 24 is the recorded endpoint.

Show the evidence

biomarkers

  • low density lipoprotein cholesterol at week 24; 2026-09-01
  • one or more adverse events; 2026-09-01
  • who discontinued study drug due to an ae; 2026-09-01
  • adverse events; 2026-09-01
  • low density lipoprotein cholesterol at day 56; 2026-09-01
  • who discontinue study drug due to an ae; 2026-09-01
14 more recorded rows
  • biomarkers
    maximum plasma concentration of enlicitide in plasma; 2026-09-01
  • biomarkers
    maximum plasma concentration of levothyroxine; 2026-09-01
  • biomarkers
    time to maximum plasma concentration of levothyroxine; 2026-09-01
  • biomarkers
    maximum plasma concentration of triiodothyronine; 2026-09-01
  • biomarkers
    time to maximum plasma concentration of triiodothyronine; 2026-09-01
  • biomarkers
    who experience one or more adverse events; 2026-09-01
  • biomarkers
    who discontinue study intervention due to an ae; 2026-09-01
  • biomarkers
    maximum plasma concentration of warfarin; 2026-09-01
  • biomarkers
    time to maximum plasma concentration of warfarin; 2026-09-01
  • biomarkers
    apparent terminal half life of warfarin; 2026-09-01
  • biomarkers
    apparent clearance of warfarin; 2026-09-01
  • biomarkers
    maximum plasma concentration of lisinopril; 2026-09-01
  • biomarkers
    who experience an adverse event; 2026-09-01
  • biomarkers
    who discontinue study treatment due to an ae; 2026-09-01
  • human trials at or under30
    9
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    16; NCT06719544; PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED

Which of adverse events, apparent clearance of warfarin and apparent terminal half life of warfarin did ENLICITIDE DECANOATE's trials measure?


adverse events, apparent clearance of warfarin and apparent terminal half life of warfarin lead 20 outcome terms across ENLICITIDE DECANOATE's trials. ClinicalTrials.gov · 2026-09-01

adverse events, low density lipoprotein cholesterol at day 56, who discontinue study drug due to an ae, maximum plasma concentration of enlicitide in plasma, maximum plasma concentration of levothyroxine and time to maximum plasma concentration of levothyroxine follow.

Show the evidence
  • low density lipoprotein cholesterol at week 24
    1
  • one or more adverse events
    1
  • who discontinued study drug due to an ae
    1
  • adverse events
    1
  • low density lipoprotein cholesterol at day 56
    1
  • who discontinue study drug due to an ae
    1
14 more recorded rows
  • maximum plasma concentration of enlicitide in plasma
    1
  • maximum plasma concentration of levothyroxine
    1
  • time to maximum plasma concentration of levothyroxine
    1
  • maximum plasma concentration of triiodothyronine
    1
  • time to maximum plasma concentration of triiodothyronine
    1
  • who experience one or more adverse events
    1
  • who discontinue study intervention due to an ae
    1
  • maximum plasma concentration of warfarin
    1
  • time to maximum plasma concentration of warfarin
    1
  • apparent terminal half life of warfarin
    1
  • apparent clearance of warfarin
    1
  • maximum plasma concentration of lisinopril
    1
  • who experience an adverse event
    1
  • who discontinue study treatment due to an ae
    1

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

Which of ENLICITIDE DECANOATE's 7 ongoing trials reports first?


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

Blinded Period: Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus; Number of participants with one or more adverse events (AEs); latest 2037-01-23

Show the evidence

Trial

  • NCT06008756
    "Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes"; n 14550; "Blinded Period: Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus"; 2031-11-29
  • NCT06492291
    "Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension"; n 3000; "Number of participants with one or more adverse events (AEs)"; 2028-10-13
  • NCT07058077
    "A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)"; n 153; "Part A: Maximum Plasma Concentration (Cmax) of Enlicitide"; 2037-01-23
  • NCT07216482
    "A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)"; n 996; "Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)"; 2026-11-05
  • NCT07614984
    "A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)"; n 750; "Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8"; 2027-10-12
  • NCT07619443
    "A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003)"; n 30; "Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-7262"; 2026-09-12
  • 1 further recorded trial NCT07776665
    "A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)"; n 30; "Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Enlicitide in Plasma"; 2026-12-21

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

Which 6 trials of ENLICITIDE DECANOATE posted no result?


Posted no result
6 of 6 completed trials
Registrations
NCT06658652, NCT06699355, NCT06691906, NCT06699329, NCT06772779 and NCT06772792
Completion dates
oldest 2023-12-26; newest 2024-06-21
Show the evidence

Trial

  • NCT06658652
    2023-12-26
  • NCT06699355
    2023-12-29
  • NCT06691906
    2024-05-01
  • NCT06699329
    2024-05-24
  • NCT06772779
    2024-06-04
  • NCT06772792
    2024-06-21

At the median, ENLICITIDE DECANOATE's trials enrolled 36 people — anything larger?


Median enrolment
36
Largest enrolment
14550
Registered trials counted
25
Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL6068420
PubChem CID
172866837
CAS number
2861205-06-1
InChIKey
ZJMSWDDEBKNMLX-HMPNVHCESA-O

Relations

Also called
Mk-0616
Trade name
Lipfendra
Sources (4)

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 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 4 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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