A clinical study of enlicitide in people with high cholesterol (MK-0616-037)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

20 Dec 2025 → ongoing

Decision date (initial)

2025-11-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-521495-54-00

WHO UTN

U1111-1319-9502

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacogenomic, Safety, Efficacy, Pharmacogenetic

To compare the efficacy of enlicitide + rosuvastatin against placebo on mean percent change from baseline LDL-C at Week 8.

Secondary objectives 11

1. To compare the efficacy of enlicitide monotherapy against placebo on mean percent change from baseline LDL-C at Week 8.
2. To compare the efficacy of enlicitide + rosuvastatin against rosuvastatin monotherapy and enlicitide monotherapy on mean percent change from baseline LDL-C at Week 8.
3. To compare the efficacy of enlicitide + rosuvastatin against placebo on mean percent change from baseline ApoB at Week 8.
4. To compare the efficacy of enlicitide monotherapy against placebo on mean percent change from baseline ApoB at Week 8.
5. To compare the efficacy of enlicitide + rosuvastatin against rosuvastatin monotherapy and enlicitide monotherapy on mean percent change from baseline ApoB at Week 8.
6. To evaluate the safety and tolerability of enlicitide + rosuvastatin, enlicitide monotherapy, and rosuvastatin monotherapy.
7. To evaluate the efficacy of the following with respect to the mean percent change from baseline in LDL-C at Week 12: -Enlicitide + rosuvastatin compared with placebo, enlicitide monotherapy, and rosuvastatin monotherapy -Enlicitide monotherapy compared with placebo
8. To evaluate the efficacy of the following with respect to the mean percent change from baseline in non-HDL-C at Week 8: -Enlicitide + rosuvastatin compared with placebo, enlicitide monotherapy, and rosuvastatin monotherapy -Enlicitide monotherapy compared with placebo
9. To evaluate the efficacy of the following with respect to percent change from baseline in Lp(a) at Week 8: -Enlicitide + rosuvastatin compared with placebo, enlicitide monotherapy, and rosuvastatin monotherapy -Enlicitide monotherapy compared with placebo
10. To evaluate the efficacy of the following with respect to the proportion of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 8: -Enlicitide + rosuvastatin compared with placebo, enlicitide monotherapy, and rosuvastatin monotherapy -Enlicitide monotherapy compared with placebo
11. To evaluate the efficacy of the following with respect to the proportion of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 8: -Enlicitide + rosuvastatin compared with placebo, enlicitide monotherapy, and rosuvastatin monotherapy -Enlicitide monotherapy compared with placebo

Conditions and MedDRA coding

Hyperlipidemia

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
2. Is an individual of any sex/gender, from 18 years to 64 years age inclusive.

Exclusion criteria 8

1. Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
2. Had a heart failure hospitalization within 3 months before Screening.
3. Is unwilling to take a statin, and/or has a history of statin-associated muscle symptoms or other statin-related AEs to any statin and dose, and/or is known to be intolerant to 1 or more statins.
4. Has a history of any of the following conditions: (1) Myopathy, myositis, rhabdomyolysis, or unexplained muscle pain; (2) Muscular or neuromuscular disease; (3) Neuropathy, fibromyalgia, or chronic pain; or (4) Has a personal or family history of hereditary muscular disorders.
5. Has active or chronic hepatobiliary or hepatic disease.
6. Has known human immunodeficiency virus (HIV) infection.
7. Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program.
8. Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)

Secondary endpoints 9

1. Mean Percent Change from Baseline in LDL-C at Week 8
2. Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8
3. Number of Participants with One or More Adverse Events (AEs)
4. Number of Participants who Discontinue Study Drug Due to One or More AEs
5. Mean Percent Change from Baseline in LDL-C at Week 12
6. Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8
7. Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8
8. Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8
9. Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Min Zhuo

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Min Zhuo

Third parties 3

Locations

2 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications