A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide.

Navar AM, Mikhailova E, Catapano AL, Banka P, Blom DJ, Cadena A, Kourpanidis S, Lepor NE, Tsukamoto K, Mendizabal G, Nunez J, Zhang W, Zhu P, Zhuo M, Ballantyne CM

The New England journal of medicine1 Feb 2026Cited by 34 (Europe PMC)

PMID41879224DOI10.1056/nejmoa2511002PepBankPUB-41879224

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with prior or elevated risk of an atherosclerotic cardiovascular event, enlicitide reduced LDL cholesterol more than placebo at week 24.
In plain wordsIn adults with cardiovascular risk, enlicitide reduced LDL cholesterol more than placebo at week 24.
Peptide
Enlicitide
Outcome
DecreaseLDL cholesterol change at week 24
Study
n = 2,909
Comparator
Placebo
Analysis
Primary
Outcome group
Lipids · Metabolic and weight
Studied dose
20 mg daily · oral · 52 weeksAs given in this study (human).
Measurements
LDL cholesterol change
−57.1%
enlicitide
Adjusted difference
−55.8 percentage points
versus placebo
LDL cholesterol change
3%
placebo
Source sentences
Summary
The mean percent change in LDL cholesterol levels at week 24 was -57.1% (95% confidence interval [CI], -61.8 to -52.5) with enlicitide and 3.0% (95% CI, 0.9 to 5.1) with placebo, representing an adjusted between-group difference of -55.8 percentage points (95% CI, -60.9 to -50.7; P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multinational, double-blind, randomized, placebo-controlled trial
Summary · context
Participants were assigned in a 2:1 ratio to receive enlicitide at a dose of 20 mg or placebo daily for 52 weeks.
Report a problemFND-4187922401
02HumanRandomized controlled trialEfficacy outcome
In adults with cardiovascular risk, enlicitide reduced LDL cholesterol more than placebo at week 52.
In plain wordsIn adults with cardiovascular risk, enlicitide reduced LDL cholesterol more than placebo at week 52.
Peptide
Enlicitide
Outcome
DecreaseLDL cholesterol change at week 52
Study
n = 2,909
Comparator
Placebo
Analysis
Secondary
Outcome group
Lipids · Metabolic and weight
Studied dose
20 mg daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
The mean percent change in LDL cholesterol level at week 52, the mean percent changes in non-HDL cholesterol and apolipoprotein B levels at week 24, and the percent change in lipoprotein(a) levels at week 24 were significantly greater with enlicitide than with placebo (P<0.001 for all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multinational, double-blind, randomized, placebo-controlled trial
Summary · context
Participants were assigned in a 2:1 ratio to receive enlicitide at a dose of 20 mg or placebo daily for 52 weeks.
Report a problemFND-4187922402
03HumanRandomized controlled trialEfficacy outcome
In adults with cardiovascular risk, enlicitide reduced non-HDL cholesterol more than placebo at week 24.
In plain wordsIn adults with cardiovascular risk, enlicitide reduced non-HDL cholesterol more than placebo at week 24.
Peptide
Enlicitide
Outcome
DecreaseNon-HDL cholesterol change at week 24
Study
n = 2,909
Comparator
Placebo
Analysis
Secondary
Outcome group
Lipids · Metabolic and weight
Studied dose
20 mg daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
The mean percent change in LDL cholesterol level at week 52, the mean percent changes in non-HDL cholesterol and apolipoprotein B levels at week 24, and the percent change in lipoprotein(a) levels at week 24 were significantly greater with enlicitide than with placebo (P<0.001 for all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multinational, double-blind, randomized, placebo-controlled trial
Summary · context
Participants were assigned in a 2:1 ratio to receive enlicitide at a dose of 20 mg or placebo daily for 52 weeks.
Report a problemFND-4187922403
04HumanRandomized controlled trialEfficacy outcome
In adults with cardiovascular risk, enlicitide reduced apolipoprotein B more than placebo at week 24.
In plain wordsIn adults with cardiovascular risk, enlicitide reduced apolipoprotein B more than placebo at week 24.
Peptide
Enlicitide
Outcome
DecreaseApolipoprotein B change at week 24
Study
n = 2,909
Comparator
Placebo
Analysis
Secondary
Outcome group
Lipids · Metabolic and weight
Studied dose
20 mg daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
The mean percent change in LDL cholesterol level at week 52, the mean percent changes in non-HDL cholesterol and apolipoprotein B levels at week 24, and the percent change in lipoprotein(a) levels at week 24 were significantly greater with enlicitide than with placebo (P<0.001 for all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multinational, double-blind, randomized, placebo-controlled trial
Summary · context
Participants were assigned in a 2:1 ratio to receive enlicitide at a dose of 20 mg or placebo daily for 52 weeks.
Report a problemFND-4187922404
05HumanRandomized controlled trialEfficacy outcome
In adults with cardiovascular risk, enlicitide reduced lipoprotein(a) more than placebo at week 24.
In plain wordsIn adults with cardiovascular risk, enlicitide reduced lipoprotein(a) more than placebo at week 24.
Peptide
Enlicitide
Outcome
DecreaseLipoprotein(a) change at week 24
Study
n = 2,909
Comparator
Placebo
Analysis
Secondary
Outcome group
Lipids · Metabolic and weight
Studied dose
20 mg daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
The mean percent change in LDL cholesterol level at week 52, the mean percent changes in non-HDL cholesterol and apolipoprotein B levels at week 24, and the percent change in lipoprotein(a) levels at week 24 were significantly greater with enlicitide than with placebo (P<0.001 for all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multinational, double-blind, randomized, placebo-controlled trial
Summary · context
Participants were assigned in a 2:1 ratio to receive enlicitide at a dose of 20 mg or placebo daily for 52 weeks.
Report a problemFND-4187922405
06HumanRandomized controlled trialSafety outcome
In adults with cardiovascular risk, adverse event incidence did not appear to differ between enlicitide and placebo.
In plain wordsIn adults with cardiovascular risk, adverse events appeared similar with enlicitide and placebo.
Peptide
Enlicitide
Outcome
No significant changeAdverse event incidence
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
20 mg daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
The incidence of adverse events did not appear to differ between the groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multinational, double-blind, randomized, placebo-controlled trial
Summary · context
Participants were assigned in a 2:1 ratio to receive enlicitide at a dose of 20 mg or placebo daily for 52 weeks.
Report a problemFND-4187922406

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT05952856

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

Merck Sharp & Dohme LLCn = 2,91210 Aug 2023 to 28 Jul 2025

Hypercholesterolemia · Familial Hypercholesterolemia

Trial page ClinicalTrials.govUpdated 24 Sept 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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