A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Merck Sharp & Dohme LLCn = 15015 Oct 2026 to est. 26 Nov 2027
Hyperlipidemia · Hypercholesterolemia
PepBank has 6 enlicitide studies with results. 5 of them gave enlicitide, with 33 results, grouped by what the studies measured. In each group, results from studies in people come first. Data as of 2026-10-30.
Searches 33 results and 47 papers. Newer studies from Europe PMC
Identifiers, parent molecule, targets and development stage, from curated data.
Enlicitide is a synthetic macrocyclic peptide that binds PCSK9 and inhibits its interaction with LDL receptors. Lipfendra tablets contain the decanoate salt. The active cation and the formulated salt have different molecular formulas.
| Target | Action | Evidence |
|---|---|---|
| PCSK9PCSK9Q8NBP7 (opens in a new tab) | Inhibitor | DailyMed section 12.1 establishes PCSK9 binding and inhibition of the PCSK9-LDLR interaction.Source (opens in a new tab) |
Residues, differences from the parent, calculated properties and 3D structure. Source values and calculated values are shown separately.
Sequence not disclosed
The formula, mass, SMILES and InChIKey describe the enlicitide cation, not its decanoate salt. PubChem, ChEMBL and IUPHAR agree on the stereochemical InChIKey. The label gives C92H129FN14O17 and 1722.12 g/mol for enlicitide decanoate. The chemical name specifies both L- and D-residues, two lactam closures and an ether closure. No standard linear sequence, residue count, terminal assignment or HELM was established. Empty modification positions do not imply an unmodified peptide.
No sequence is listed, so nothing can be calculated.
No charge curve
No sequence is listed for this peptide.
No sequence is listed for this peptide.
No 3D structure
No experimental structure (PDB) and no UniProt entry for an AlphaFold model are listed for this peptide. Synthetic peptides often have neither. The sequence view above is the reference.
Draws the structure in your browser with RDKit (about 2.3 MB, loaded once).
SMILES fromPubChem CID 164933665(opens in a new tab)
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)CPeople first in each area, then animals, then lab cells. Counts are exact and come from studies that gave the peptide.
PepBank reads each paper before it shows the results. This search looks in Europe PMC for newer papers that PepBank has not read yet.
Counts are exact and come from studies that gave the peptide.
Studies by year
6 of 47 studies have results (13%), published 2023 to 2026. Top row: every study. Bottom row: studies with results about Enlicitide, by class. The rows use different scales.
Studies47 in all, 2006 to 2026
Studies with results6 in all, 2023 to 2026
Retracted studies are left out. A study with results in two classes counts in both.
AI wrote and checked these results. AI can make mistakes, so check important results against the source.
Registered trials that test the peptide, with phase, status and dates. A dot marks trials with posted results.
34 trials match. Highest phase first. Data from ClinicalTrials.gov.
25 of 34 trials
A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)
NCT0507039016 Nov 2021 to 3 May 2023
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
NCT0526112610 Mar 2022 to 28 Nov 2022
A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)
NCT068141066 Mar 2023 to 8 May 2023
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
NCT0593429220 Jul 2023 to 19 Jan 2024
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
NCT059528698 Aug 2023 to 7 Apr 2025
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
NCT0595285610 Aug 2023 to 28 Jul 2025
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
NCT060087569 Oct 2023 to est. 29 Nov 2031
A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)
NCT067727791 Apr 2024 to 4 Jun 2024
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)
NCT0677279223 Apr 2024 to 21 Jun 2024
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)
NCT064503668 Jul 2024 to 28 Mar 2025
25 trials · 8 ongoing · 17 completed · 8 with posted results · source ClinicalTrials.gov (opens in a new tab)
Merck Sharp & Dohme LLCn = 15015 Oct 2026 to est. 26 Nov 2027
Hyperlipidemia · Hypercholesterolemia
Merck Sharp & Dohme LLCn = 15321 Aug 2025 to est. 23 Jan 2037
Heterozygous Familial Hypercholesterolemia (HeFH)
Merck Sharp & Dohme LLCn = 2,91210 Aug 2023 to 28 Jul 2025
Hypercholesterolemia · Familial Hypercholesterolemia
Merck Sharp & Dohme LLCn = 99611 Nov 2025 to est. 5 Nov 2026
Hyperlipidemia
Merck Sharp & Dohme LLCn = 14,5509 Oct 2023 to est. 29 Nov 2031
Arteriosclerosis · Hypercholesterolaemia
Merck Sharp & Dohme LLCn = 3018 Jul 2024 to 28 Mar 2025
Hypercholesterolemia
Merck Sharp & Dohme LLCn = 3038 Aug 2023 to 7 Apr 2025
Hypercholesterolemia · Familial Hypercholesterolemia
Merck Sharp & Dohme LLCn = 3,0005 Aug 2024 to est. 13 Oct 2028
Hypercholesterolemia
Merck Sharp & Dohme LLCn = 75030 Jun 2026 to est. 12 Oct 2027
Lipoprotein(a)
Merck Sharp & Dohme LLCn = 38110 Mar 2022 to 28 Nov 2022
Hypercholesterolemia · Familial Hypercholesterolemia
Merck Sharp & Dohme LLCn = 2722 Nov 2024 to 25 Jun 2025
Healthy · Renal Impairment
Merck Sharp & Dohme LLCn = 3320 Jul 2023 to 19 Jan 2024
Hypercholesterolaemia
Merck Sharp & Dohme LLCn = 301 Jul 2026 to 22 Sept 2026
Healthy
Merck Sharp & Dohme LLCn = 6029 Dec 2025 to est. 21 Oct 2026
Healthy
Merck Sharp & Dohme LLCn = 3031 Aug 2026 to est. 21 Dec 2026
Healthy
Merck Sharp & Dohme LLCn = 1816 Nov 2021 to 3 May 2023
Moderate Renal Impairment
Merck Sharp & Dohme LLCn = 3023 Mar 2026 to 25 May 2026
Healthy
Merck Sharp & Dohme LLCn = 2020 Sept 2024 to 8 May 2025
Hepatic Insufficiency · Hepatic Impairment
Merck Sharp & Dohme LLCn = 603 Jul 2025 to 28 Aug 2025
Healthy
Merck Sharp & Dohme LLCn = 402 Apr 2025 to 31 May 2025
Healthy
Merck Sharp & Dohme LLCn = 3623 Apr 2024 to 21 Jun 2024
Healthy
Merck Sharp & Dohme LLCn = 162 Jan 2025 to 6 Feb 2025
Healthy
Merck Sharp & Dohme LLCn = 2021 Oct 2024 to 31 Jan 2025
Healthy
Merck Sharp & Dohme LLCn = 376 Mar 2023 to 8 May 2023
Healthy
Merck Sharp & Dohme LLCn = 361 Apr 2024 to 4 Jun 2024
Healthy
Studies on this peptide. Some have results. The others have none yet.
47 studies match. Retracted studies are left out.
Showing 25 of 47 studiesquery qry_8df66b84acad8e059730a127
6 studies in all, 5 on this page
Randomized controlled trial · 2023
Ballantyne et al. 2023Journal of the American College of Cardiologycited by 162
PMID 36889610DOI 10.1016/j.jacc.2023.02.018PUB-36889610
Non-randomized trial · 2023
Johns et al. 2023Circulationcited by 119
PMID 37125593PMC10325562DOI 10.1161/circulationaha.122.063372PUB-37125593
Randomized controlled trial · 2026
Ballantyne et al. 2026JAMAn = 303cited by 34
PMID 41206969PMC12598580DOI 10.1001/jama.2025.20620PUB-41206969
Randomized controlled trial · 2026
Navar et al. 2026The New England journal of medicinen = 2,909cited by 34
PMID 41879224DOI 10.1056/nejmoa2511002PUB-41879224
Randomized controlled trial · 2026
Catapano et al. 2026Journal of the American College of Cardiologycited by 10
PMID 42017875DOI 10.1016/j.jacc.2026.03.036PUB-42017875
41 studies in all, 20 on this page
PubMed tag: review-article, Review · 2024
Chen et al. 2024Cardiovascular diabetologycited by 25
PMID 38195542PMC10777520DOI 10.1186/s12933-024-02119-zPUB-38195542
PubMed tag: none · 2025
Li et al. 2025Journal of the American Chemical Societycited by 25
PMID 40123407DOI 10.1021/jacs.4c15966PUB-40123407
PubMed tag: Review · 2023
Burnett et al. 2023Expert opinion on investigational drugscited by 24
PMID 37815341DOI 10.1080/13543784.2023.2267972PUB-37815341
PubMed tag: Review · 2025
Gare et al. 2025Trends in biochemical sciencescited by 24
PMID 40011178DOI 10.1016/j.tibs.2025.01.009PUB-40011178
PubMed tag: Review · 2024
Katzmann et al. 2024Current opinion in lipidologycited by 20
PMID 38277255DOI 10.1097/mol.0000000000000919PUB-38277255
PubMed tag: review-article, Review · 2025
Ferri et al. 2025Atherosclerosis pluscited by 20
PMID 39802651PMC11722601DOI 10.1016/j.athplu.2024.11.003PUB-39802651
PubMed tag: Review · 2024
Agarwala et al. 2024Current atherosclerosis reportscited by 18
PMID 38536608DOI 10.1007/s11883-024-01199-2PUB-38536608
PubMed tag: Review · 2023
Gupta et al. 2023Current atherosclerosis reportscited by 11
PMID 37086374DOI 10.1007/s11883-023-01103-4PUB-37086374
PubMed tag: Review · 2025
Ballantyne et al. 2025European heart journalcited by 10
PMID 40911366DOI 10.1093/eurheartj/ehaf606PUB-40911366
PubMed tag: Review · 2025
Siddiqui et al. 2025Cardiology in reviewcited by 9
PMID 38285643DOI 10.1097/crd.0000000000000655PUB-38285643
PubMed tag: Review · 2025
Tokgözoğlu et al. 2025Current atherosclerosis reportscited by 9
PMID 40304930DOI 10.1007/s11883-025-01299-7PUB-40304930
PubMed tag: Review · 2026
Abdul Jabbar et al. 2026Current atherosclerosis reportscited by 6
PMID 41493497DOI 10.1007/s11883-025-01376-xPUB-41493497
PubMed tag: Review · 2024
Faluk et al. 2024Current problems in cardiologycited by 4
PMID 38735347DOI 10.1016/j.cpcardiol.2024.102637PUB-38735347
PubMed tag: Meta-Analysis, Systematic Review · 2026
Masson et al. 2026Advances in therapycited by 4
PMID 41288928PMC12858574DOI 10.1007/s12325-025-03418-xPUB-41288928
PubMed tag: Review · 2025
Ma et al. 2025Journal of medicinal chemistrycited by 3
PMID 41348552DOI 10.1021/acs.jmedchem.5c02276PUB-41348552
PubMed tag: review-article, Review · 2026
Niazi et al. 2026Frontiers in drug deliverycited by 3
PMID 41939723PMC13047097DOI 10.3389/fddev.2026.1776167PUB-41939723
PubMed tag: none · 2026
Josien et al. 2026Journal of medicinal chemistrycited by 3
PMID 42201324DOI 10.1021/acs.jmedchem.6c00463PUB-42201324
PubMed tag: review-article, Review · 2025
Campeau et al. 2025The Journal of organic chemistrycited by 2
PMID 40168664PMC11998012DOI 10.1021/acs.joc.4c02919PUB-40168664
PubMed tag: review-article, Review · 2026
Amorosi et al. 2026Atherosclerosis pluscited by 1
PMID 41907045PMC13018980DOI 10.1016/j.athplu.2025.12.001PUB-41907045
PubMed tag: none · 2026
Olmastroni et al. 2026European journal of preventive cardiologycited by 1
PMID 42169510DOI 10.1093/eurjpc/zwag273PUB-42169510
Page 1 of 1
Navar AM · The New England journal of medicine · 2026
Randomized controlled trial · 6 results
Ballantyne CM · JAMA · 2026
Randomized controlled trial · 8 results
Ballantyne CM · Journal of the American College of Cardiology · 2023
Randomized controlled trial · 6 results
Catapano AL · Journal of the American College of Cardiology · 2026
Randomized controlled trial · 11 results
Johns DG · Circulation · 2023
Non-randomized trial · 2 results
Cariou B · Atherosclerosis · 2026
Not a test of Enlicitide alone · 2 results
Approval and sport status, and the safety outcomes reported in study results. Laws and labels change, so check the regulator for the current status.
| Jurisdiction | Body | Status | As of | Source |
|---|---|---|---|---|
| US | FDA |
| 27 Oct 2026 | accessdata.fda.gov (opens in a new tab) |
| EU | EMA | EMA records a paediatric investigation plan and its modification. These decisions do not establish marketing authorization. EU marketing authorization was not established. | 27 Oct 2026 | ema.europa.eu (opens in a new tab) |
| Sport | WADA | Status unknown Enlicitide and MK-0616 are not named in the 2026 list. | 2026 List | wada-ama.org (opens in a new tab) |
8 safety results for Enlicitide.
In adults with HeFH, adverse event incidence was similar with enlicitide and placebo.
Randomized controlled trialn = 303
In adults with HeFH, serious adverse event incidence was similar with enlicitide and placebo.
Randomized controlled trialn = 303
In adults with HeFH, discontinuation due to adverse events was similar with enlicitide and placebo.
Randomized controlled trialn = 303
In adults with hypercholesterolemia, adverse events occurred in 39.5% to 43.4% of participants across the MK-0616 arms and in 44.0% with placebo.
Randomized controlled trialn not reported
In adults with hypercholesterolemia, adverse events caused discontinuation in 2 or fewer participants per treatment group, including MK-0616 groups.
Randomized controlled trialn not reported
In adults with cardiovascular risk, adverse event incidence did not appear to differ between enlicitide and placebo.
Randomized controlled trialn not reported
In statin-treated adults, adverse event proportions were similar across enlicitide and the other treatment arms.
Randomized controlled trialn not reported
In statin-treated adults, discontinuations due to adverse events were similar across enlicitide and the other treatment arms.
Randomized controlled trialn not reported
The doses that these studies used. They are not recommendations.
20 mg dailyHuman
20 mg once dailyHuman
6 mg once dailyHuman
12 mg once dailyHuman
18 mg once dailyHuman
30 mg once dailyHuman
6 of 9 shown
PepBank is a research reference. Talk to a doctor before you use any peptide.
Data version, change history and code for this peptide.
curl -s https:// pepbank.io/ v1/ briefs/ enlicitideEvidence summary for Enlicitide: counts by class, key results with sources, notices, data version.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Top outcomes
The 3 outcome groups with the most study results, by evidence class.
Data version 308560. Bar length is the number of results, not the size of an effect.
Evidence matrix
Study results by outcome and evidence class. Arrows show how the measured outcome moved, not whether the change is good.
| Outcome group | Human | Animal | Lab | Computer model | Total |
|---|---|---|---|---|---|
| LipidsMetabolic and weight | Human: 24 results from 5 studies: 24 decrease. Strongest design: Randomized controlled trial | No results | No results | No results | 24 |
| Adverse eventsWhole body | Human: 8 results from 4 studies: 7 no significant change, 1 not reported. Strongest design: Randomized controlled trial | No results | No results | No results | 8 |
| Receptor activity and mechanismPharmacology | Human: 1 result from 1 study: 1 decrease. Strongest design: Non-randomized trial | No results | No results | No results | 1 |
3 outcome groups shown of 3 · 33 study results
Data version 308560. Shade grows with the number of results. Every cell shows the exact count.
Trials by phase
25 registered trials loaded of 34, grouped by phase and shown by status.
Source: ClinicalTrials.gov, data version 308560. Status is the registry status. The counts cover only the loaded trials.