Peptides / Weight and metabolic

Synthetic analog · 1,550.8 Da

Enlicitide

Approved

Enlicitide (Lipfendra) is an oral macrocyclic peptide PCSK9 inhibitor approved in the US to lower LDL cholesterol in adults with high cholesterol, alongside diet and exercise. Studies in people tested it mostly on LDL cholesterol and other blood fats, and tracked side effects. PepBank shows 33 results on enlicitide from 5 studies in people. The strongest evidence is a randomized trial in people. Data as of 2026-10-30.

Also known as MK-0616, enlicitide decanoate, Lipfendra

Evidence level: Large trials in people33 of 33 results come from studies in people, including randomized trials.

Results in people

100% of 33 results

Results in animals

0% of 33 results

Results in lab cells

0% of 33 results

From computer models

0% of 33 results

Overview

Enlicitide at a glance

What it is	Synthetic analog
Approval	Approved in the US (Lipfendra, 2026)
In sport	Status unknown
Studies	6 studies with results. 5 of them gave enlicitide, with 33 results. 33 in people
Best study in people	Randomized controlled trial with 2,909 people (2026)
Clinical trials	34 registered: 8 active or planned, 8 with posted results
Community use	Adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia

The science

What is enlicitide?

An oral macrocyclic peptide PCSK9 inhibitor used to lower LDL cholesterol.

Study results in PepBank

The history of enlicitide

2006
The oldest paper on enlicitide in PepBank is from 2006.
2022March
A registered trial of enlicitide started (NCT05261126).
2026July
FDA approved Lipfendra for adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

Enlicitide structure and chemistry

The key facts about the molecule. Long codes are in the closed section below.

Structure

Enlicitide is a synthetic analog, with a ring, 3 changed amino acids.

Formula

C₈₂H₁₁₀FN₁₄O₁₅+

Molecular weight

1,550.8 g/mol

CAS number

2407527-14-2

Target

PCSK9 (gene PCSK9): inhibitorEvidence: DailyMed section 12.1 establishes PCSK9 binding and inhibition of the PCSK9-LDLR interaction.

Development

Merck Sharp & Dohme LLC. Highest phase: past the trial stage (see status).

Identifiers

PubChem 164933665, ChEMBL CHEMBL6068773, UNII R7EZ772VG2, DrugBank DB22580, IUPHAR 13944

SMILES and InChIKey

InChIKey
ZJMSWDDEBKNMLX-HMPNVHCESA-O

SMILES
C[C@H]1C(=O)N[C@@H](C(=O)N[C@H]2CC3=CC(=CC=C3)CNC(=O)CO[C@H]4CCN5[C@@H]4C(=O)N[C@H](C(=O)N[C@H](C(=O)N6CCC[C@]6(C(=O)NCCC7=CC=C(CN(CCCCCCN8C=C(C[C@@H](C5=O)NC2=O)C9=C8C=CC(=C9)F)C(=O)CCC(=O)N1)C=C7)C)CC1=CC=C(C=C1)OC)[C@@H](C)O)CNC(=O)CCCCC[N+](C)(C)C

See charge, composition and 3D structure on the Scientific page

The evidence

What enlicitide studies show

Results grouped by what the studies measured. Each card shows where its results come from.

Large trials in people33 of 33 results come from studies in people, including randomized trials.

Cholesterol and blood fats

24 results · 24 in people

In adults with cardiovascular risk, enlicitide reduced LDL cholesterol more than placebo at week 24. The New England journal of medicine, 2026

All 5 studies in people

In people

In adults with cardiovascular risk, enlicitide reduced LDL cholesterol more than placebo at week 24.

2026The New England journal of medicine2,909 people

In people

In adults with inherited high cholesterol, enlicitide reduced LDL cholesterol more than placebo at week 24.

2026JAMA303 people

In people

In adults with hypercholesterolemia, MK-0616 at 6 mg reduced LDL-C more than placebo.

2023Journal of the American College of Cardiology

In people

Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial.

2026Journal of the American College of Cardiology

In people

In healthy adults, free unbound plasma PCSK9 decreased after single oral MK-0616 doses.

2023Circulation

All 6 enlicitide studies by area Open the Scientific page

Key enlicitide studies

Studies in people come first, then studies in animals and in the lab.

People
A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide
Navar et al. 2026 · The New England journal of medicine · 2,909 people · cited by 34
6 results
People
Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial
Ballantyne et al. 2026 · JAMA · 303 people · cited by 34
8 results
People
Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616
Ballantyne et al. 2023 · Journal of the American College of Cardiology · cited by 162
6 results
People
Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial
Catapano et al. 2026 · Journal of the American College of Cardiology · cited by 10
11 results
People
Orally Bioavailable Macrocyclic Peptide That Inhibits Binding of PCSK9 to the Low Density Lipoprotein Receptor
Johns et al. 2023 · Circulation · cited by 119
2 results

All 6 Enlicitide studies

Enlicitide clinical trials

ClinicalTrials.gov lists 34 trials of enlicitide. 8 are active or planned, and 8 have posted results. PepBank does not show trial results.

Solid bars are dates that happened. Hatched bars are planned dates. Data from ClinicalTrials.gov.

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

Phase 3completed2,912 people

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

Phase 3completed303 people

A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

Phase 3completed301 people

All 8 Enlicitide trials

Status and safety

Is enlicitide approved?

FDA

United States

Approved

An approved medicine contains it.

EMA

European Union

Status unknown

Status unknown.

WADA

Sport

Not recorded

Status unknown.

Yes. Approved in the US (Lipfendra, 2026). The FDA label for Lipfendra says: “Adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia” Status unknown.

Laws and labels change, so check the regulator for the current status.

Enlicitide side effects and safety

PepBank has 8 safety results from studies of enlicitide. 8 of them come from studies in people.

Safety results from studies (8)

In adults with hypercholesterolemia, adverse event proportions were similar with MK-0616 and placebo. (Journal of the American College of Cardiology, 2023)
In adults with inherited high cholesterol, adverse event rates were similar with enlicitide and placebo. (JAMA, 2026)
In adults with cardiovascular risk, adverse events appeared similar with enlicitide and placebo. (The New England journal of medicine, 2026)
In statin-treated adults, adverse event proportions were similar across enlicitide and the other treatment arms. (Journal of the American College of Cardiology, 2026)
In adults with hypercholesterolemia, adverse events caused discontinuation in 2 or fewer participants per group, including MK-0616 groups. (Journal of the American College of Cardiology, 2023)
In adults with inherited high cholesterol, serious adverse event rates were similar with enlicitide and placebo. (JAMA, 2026)
In adults with inherited high cholesterol, study discontinuation due to adverse events was similar with enlicitide and placebo. (JAMA, 2026)
In statin-treated adults, discontinuations for adverse events were similar across enlicitide and the other treatment arms. (Journal of the American College of Cardiology, 2026)

See every safety result on the Scientific page

Doses studied (9 shown)

The doses that these studies used. They are not recommendations.

Dose as reported	Class	Species	Route	Duration	Design	Source
20 mg daily	Human	human	oral	52 weeks	Randomized trial in people · n = 2,909	Navar 2026
20 mg once daily	Human	human	oral	52 weeks	Randomized trial in people · n = 303	Ballantyne 2026
6 mg once daily	Human	human	oral	8 weeks	Randomized trial in people	Ballantyne 2023
12 mg once daily	Human	human	oral	8 weeks	Randomized trial in people	Ballantyne 2023
18 mg once daily	Human	human	oral	8 weeks	Randomized trial in people	Ballantyne 2023
30 mg once daily	Human	human	oral	8 weeks	Randomized trial in people	Ballantyne 2023
6, 12, 18 or 30 mg once daily	Human	human	oral	8 weeks	Randomized trial in people	Ballantyne 2023
20 mg once daily	Human	human	oral	56 days	Randomized trial in people	Catapano 2026
20 mg once daily	Human	human	oral	14 days	Trial in people without random groups	Johns 2023

From the community

How people use it

What people report online. It comes from forums and guides, not from studies.

Community-reported. Not tested in trials.

The approved US label describes an oral regimen. This record does not establish separate community practice.

Reported routines and cautions

What people use it for

Adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemiaS1

Reported regimens

Regimens that community sources report for Enlicitide. Community-reported, not tested in trials.
Context	Route	Amount	How often	How long	Agreement	Sources
Adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemiaOfficial label dosing of an approved product	oral	20 mg per dose	once daily	Not stated	Official product instructions.	S1

Community sources

S1LIPFENDRA prescribing information (opens in a new tab)dailymed.nlm.nih.gov

Gaps

Separate community use was not established.

Questions and more

Ask a question about enlicitide

The answer links to every study it uses.

What does the evidence say about enlicitide?Is enlicitide tested in people?Compare with Semaglutide Compare with Liraglutide

Sources

Database: PepBank data for enlicitide (data version 308560)
Regulator: FDA status record
Regulator: EMA status record
Regulator: WADA status record
Trial registry: ClinicalTrials.gov
Community: community sources (forums and guides), as summarized in the PepBank community file

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

PepBank is a research reference. Talk to a doctor before you use any peptide.

Ask your AI about enlicitide

Enlicitide

Enlicitide at a glance

What is enlicitide?

The history of enlicitide

Enlicitide structure and chemistry

What enlicitide studies show

Cholesterol and blood fats

All 5 studies in people

Key enlicitide studies

Enlicitide clinical trials

Is enlicitide approved?

Enlicitide side effects and safety

How people use it

What people use it for

Reported regimens

Community sources

Ask a question about enlicitide

Related peptides

Sources

Enlicitide

Enlicitide at a glance

What is enlicitide?

The history of enlicitide

Enlicitide structure and chemistry

What enlicitide studies show

Cholesterol and blood fats

All 5 studies in people

Key enlicitide studies

Enlicitide clinical trials

Is enlicitide approved?

Enlicitide side effects and safety

How people use it

What people use it for

Reported regimens

Community sources

Ask a question about enlicitide

Related peptides

Sources