Primary outcomeMean· Baseline and Week 24
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
| Group | Value (Percent change) |
|---|---|
| Enlicitide Decanoate | -57.1 |
| Placebo | 3.0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
NCTNCT05952856 (opens ClinicalTrials.gov in a new tab)Other id0616-013Other idMK-0616-013Other id2022-502777-42-01Other idU1111-1285-4164
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 2,912 participants (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Design
- Randomized · Triple masking
- Countries
14 countries
United States, Argentina, China, Colombia, Germany, Israel, Italy, Japan, Mexico, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye)
- Start
- 10 Aug 2023
- Primary completion
- 28 Jul 2025
- Completion
- 28 Jul 2025
- First posted
- 19 Jul 2023
- Last update posted
- 24 Sept 2026
- Conditions
- Hypercholesterolemia · Familial Hypercholesterolemia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2023202420252026
- Ph 3
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
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Interventions
- Enlicitide DecanoateDrug
- PlaceboDrug
Arms2
Experimental
Enlicitide Decanoate
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Placebo comparator
Placebo
Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Primary outcomes3
Outcomes the sponsor listed as primary.
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C.
Number of Participants With One or More Adverse Events (AEs)
Time frame · Up to 60 weeks
Registry description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame · Up to 52 weeks
Registry description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Secondary outcomes(6)
Mean Percent Change From Baseline in LDL-C at Week 52
Time frame · Baseline and Week 52
Registry description
Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C.
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples collected at baseline and Week 24 were used to assess mean percent change in non-HDL-C.
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples collected at baseline and Week 24 were used to assess mean percent change in ApoB.
Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples collected at baseline and Week 24 were used to assess percent change in Lp(a).
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \<70 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.
Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· Up to 60 weeks
Number of Participants With One or More Adverse Events (AEs)
| Group | Value (Participants) |
|---|---|
| Enlicitide Decanoate | 1244 |
| Placebo | 602 |
Primary outcomeCount of participants· Up to 52 weeks
Number of Participants Who Discontinued Study Drug Due to an AE
| Group | Value (Participants) |
|---|---|
| Enlicitide Decanoate | 60 |
| Placebo | 40 |
Secondary and other outcome results(5)
Post hoc outcomeMean· Baseline and Week 24
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 Reanalysis (Post-hoc )
| Group | Value (Percent change) |
|---|---|
| Enlicitide Decanoate | -59.6 |
| Placebo | 3.0 |
Secondary outcomeMean· Baseline and Week 52
Mean Percent Change From Baseline in LDL-C at Week 52
| Group | Value (Percent change) |
|---|---|
| Enlicitide Decanoate | -50.4 |
| Placebo | 4.0 |
Post hoc outcomeMean· Baseline and Week 52
Mean Percent Change From Baseline in LDL-C at Week 52 Reanalysis (Post-hoc )
| Group | Value (Percent change) |
|---|---|
| Enlicitide Decanoate | -52.7 |
| Placebo | 4.0 |
Secondary outcomeMean· Baseline and Week 24
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
| Group | Value (Percent change) |
|---|---|
| Enlicitide Decanoate | -53.7 |
| Placebo | 2.6 |
Secondary outcomeMean· Baseline and Week 24
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
| Group | Value (Percent change) |
|---|---|
| Enlicitide Decanoate | -49.6 |
| Placebo | 2.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Enlicitide 20 mgParticipants received 20 mg of enlicitide decanoate orally QD for up to 52 weeks. | 15 / 1940 | 191 / 1935 | 0 / 1935 |
| PlaceboParticipants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks. | 8 / 969 | 116 / 969 | 0 / 969 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2026
6 results
A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide.
Navar et al. 2026The New England journal of medicinecited by 34
PMID 41879224DOI 10.1056/nejmoa2511002PUB-41879224
Full text at the publisher6 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
* Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
* If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change.
Exclusion Criteria:
* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
* Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
* Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
PepBank is a research reference. Talk to a doctor before you use any peptide.