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) | Spread |
|---|---|---|
| Enlicitide Decanoate | -58.2 | 28.0 |
| Placebo | 2.6 | 23.6 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
NCTNCT05952869 (opens ClinicalTrials.gov in a new tab)Other id0616-017Other idMK-0616-017Other id2022-502782-14-00Other idU1111-1285-4257
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 303 participants (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Design
- Randomized · Triple masking
- Countries
17 countries
United States, Australia, Brazil, Canada, Chile, Colombia, Czechia, Finland, Hong Kong, Hungary, Israel, Netherlands, New Zealand, Norway, Singapore, Spain, Taiwan
- Start
- 8 Aug 2023
- Primary completion
- 7 Apr 2025
- Completion
- 7 Apr 2025
- First posted
- 19 Jul 2023
- Last update posted
- 24 Feb 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 Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
NCT059528698 Aug 2023 to 7 Apr 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 heterozygous familial 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 received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Placebo comparator
Placebo
Participants received 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 were collected at baseline and at Week 24 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Number of Participants With Adverse Events (AEs)
Time frame · Up to 64 weeks (8 weeks postdose)
Registry description
An AE was defined as 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 56 weeks
Registry description
An AE was defined as 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 were collected at baseline and at Week 52 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples were collected at baseline and at Week 24 to determine mean percent change in non-HDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline non-HDL-C as a covariate.
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples were collected at baseline and at Week 24 to determine mean percent change in ApoB. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline ApoB as a covariate.
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
Time frame · Baseline and Week 24
Registry description
Blood samples were collected at baseline and at Week 24 to determine percent change in Lp(a). For percent change in Lp(a) at Week 24, the two treatment groups were analyzed using the Wilcoxon signed rank test with Hodges-Lehmann estimation.
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 were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C \<70 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
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 were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C \<55 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
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 outcomeNumber· Up to 64 weeks (8 weeks postdose)
Number of Participants With Adverse Events (AEs)
| Group | Value (Participants) |
|---|---|
| Enlicitide Decanoate | 157 |
| Placebo | 77 |
Primary outcomeNumber· Up to 56 weeks
Number of Participants Who Discontinued Study Drug Due to an AE
| Group | Value (Participants) |
|---|---|
| Enlicitide Decanoate | 4 |
| Placebo | 3 |
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline and Week 52
Mean Percent Change From Baseline in LDL-C at Week 52
| Group | Value (Percent Change) | Spread |
|---|---|---|
| Enlicitide Decanoate | -55.3 | 27.9 |
| Placebo | 8.7 | 33.0 |
Secondary outcomeMean· Baseline and Week 24
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
| Group | Value (Percent Change) | Spread |
|---|---|---|
| Enlicitide Decanoate | -52.3 | 26.9 |
| Placebo | 2.1 | 20.5 |
Secondary outcomeMean· Baseline and Week 24
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
| Group | Value (Percent Change) | Spread |
|---|---|---|
| Enlicitide Decanoate | -48.2 | 23.6 |
| Placebo | 1.8 | 17.5 |
Secondary outcomeMedian· Baseline and Week 24
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
| Group | Value (Percent Change) |
|---|---|
| Enlicitide Decanoate | -24.7 |
| Placebo | -1.6 |
Secondary outcomeNumber· Baseline and Week 24
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24
| Group | Value (Percentage of Participants) |
|---|---|
| Enlicitide Decanoate | 70.8 |
| Placebo | 1.0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Enlicitide DecanoateParticipants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks. | 1 / 202 | 9 / 202 | 102 / 202 |
| PlaceboParticipants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks. | 0 / 101 | 4 / 101 | 43 / 101 |
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
8 results
Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial.
Ballantyne et al. 2026JAMAcited by 34
PMID 41206969PMC12598580DOI 10.1001/jama.2025.20620PUB-41206969
Rights unknown8 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 possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
* Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
* Is treated with a moderate- or high-intensity statin medication
* Is on a stable dose of all background lipid-lowering therapies (LLTs) 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
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