Trial · NCT05952869

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

NCT05952869, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2026-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH). Trials, record NCT05952869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05952869

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
NCT number: NCT05952869
Status: Completed
Phases: Phase 3
Enrollment: 303 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Hypercholesterolemia, Familial Hypercholesterolemia
Interventions: Enlicitide Decanoate, Placebo
First posted: 2023-07-19
Last updated: 2026-02-24
Results first posted: 2026-02-24

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	Baseline and Week 24	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.
Primary	Number of Participants With Adverse Events (AEs)	Up to 64 weeks (8 weeks postdose)	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.
Primary	Number of Participants Who Discontinued Study Drug Due to an AE	Up to 56 weeks	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	Mean Percent Change From Baseline in LDL-C at Week 52	Baseline and Week 52	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.
Secondary	Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24	Baseline and Week 24	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.
Secondary	Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24	Baseline and Week 24	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.
Secondary	Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24	Baseline and Week 24	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.
Secondary	Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24	Baseline and Week 24	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.
Secondary	Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24	Baseline and Week 24	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	Baseline and Week 24	All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.	Percent Change	MEAN
PRIMARY	Number of Participants With Adverse Events (AEs)	Up to 64 weeks (8 weeks postdose)	All participants who received at least 1 dose of study treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).	Participants	NUMBER
PRIMARY	Number of Participants Who Discontinued Study Drug Due to an AE	Up to 56 weeks	All participants who received at least 1 dose of study treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment.	Participants	NUMBER
SECONDARY	Mean Percent Change From Baseline in LDL-C at Week 52	Baseline and Week 52	All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.	Percent Change	MEAN
SECONDARY	Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24	Baseline and Week 24	All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.	Percent Change	MEAN
SECONDARY	Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24	Baseline and Week 24	All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.	Percent Change	MEAN
SECONDARY	Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24	Baseline and Week 24	All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.	Percent Change	MEDIAN
SECONDARY	Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24	Baseline and Week 24	All participants who have received at least 1 dose of double-blind study intervention and have baseline data.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24	Baseline and Week 24	All participants who have received at least 1 dose of double-blind study intervention and have baseline data.	Percentage of Participants	NUMBER

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	Enlicitide Decanoate	-58.2	Standard Deviation 28.0	Percent Change
Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	Placebo	2.6	Standard Deviation 23.6	Percent Change
Number of Participants With Adverse Events (AEs)	Enlicitide Decanoate	157		Participants
Number of Participants With Adverse Events (AEs)	Placebo	77		Participants
Number of Participants Who Discontinued Study Drug Due to an AE	Enlicitide Decanoate	4		Participants
Number of Participants Who Discontinued Study Drug Due to an AE	Placebo	3		Participants
Mean Percent Change From Baseline in LDL-C at Week 52	Enlicitide Decanoate	-55.3	Standard Deviation 27.9	Percent Change
Mean Percent Change From Baseline in LDL-C at Week 52	Placebo	8.7	Standard Deviation 33.0	Percent Change
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24	Enlicitide Decanoate	-52.3	Standard Deviation 26.9	Percent Change
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24	Placebo	2.1	Standard Deviation 20.5	Percent Change

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Enlicitide Decanoate	202
Overall Study	STARTED	Placebo	101
Overall Study	COMPLETED	Enlicitide Decanoate	196
Overall Study	COMPLETED	Placebo	97
Overall Study	NOT COMPLETED	Enlicitide Decanoate	6
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Enlicitide Decanoate	15	202	15
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	101	2
other	Nausea	Gastrointestinal disorders	Enlicitide Decanoate	16	202	19
other	Nausea	Gastrointestinal disorders	Placebo	7	101	8
other	COVID-19	Infections and infestations	Enlicitide Decanoate	8	202	8
other	COVID-19	Infections and infestations	Placebo	11	101	11
other	Influenza	Infections and infestations	Enlicitide Decanoate	17	202	21
other	Influenza	Infections and infestations	Placebo	9	101	9
other	Nasopharyngitis	Infections and infestations	Enlicitide Decanoate	19	202	25
other	Nasopharyngitis	Infections and infestations	Placebo	8	101	10

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Enlicitide Decanoate	1	202
Total, all-cause mortality	Placebo	0	101
Total, other adverse events	Enlicitide Decanoate	102	202
Total, other adverse events	Placebo	43	101
Total, serious adverse events	Enlicitide Decanoate	9	202
Total, serious adverse events	Placebo	4	101

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41206969	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Enlicitide Decanoate vs Placebo: Number of Participants With Adverse Events (AEs)	Trial comparisons
Enlicitide Decanoate vs Placebo: deaths from any cause	Trial comparisons
Enlicitide Decanoate vs Placebo: Number of Participants Who Discontinued Study Drug Due to an AE	Trial comparisons
Enlicitide Decanoate vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05952869

GET https://conductscience.org/api/trials/v1/NCT05952869/events?page=2

API reference For AI assistants