MK-0616-013

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

16 Jan 2024 → 28 Jul 2025

Decision date (initial)

2023-12-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2022-502777-42-01

WHO UTN

U1111-1285-4164

ClinicalTrials.gov

NCT05952856

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Safety, Pharmacogenomic, Therapy, Pharmacokinetic, Efficacy, Pharmacodynamic

1.To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in LDL-C at Week 24
2.To evaluate the safety and tolerability of MK-0616

Secondary objectives 6

1. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in LDL-C at Week 52
2. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in non-HDL-C at Week 24
3. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in ApoB at Week 24
4. To evaluate the efficacy of MK-0616 compared with placebo on percent change from baseline in Lp(a) at Week 24
5. To evaluate the efficacy of MK-0616 compared with placebo on the proportion of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
6. To evaluate the efficacy of MK-0616 compared with placebo on the proportion of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24

Conditions and MedDRA coding

Hypercholesterolemia

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 5

1. Has either: a.History of a major atherosclerotic cardiovascular disease (ASCVD) event b. If no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event
2. If history of a major ASCVD event: has LDL-C ≥55 mg/dL (≥1.42 mmol/L)
3. If no history of a major ASCVD event: has LDL-C ≥70 mg/dL (≥1.81 mmol/L)
4. At time of screening, is either: a. Treated with a moderate or high-intensity statin (± non-statin lipid-lowering therapy (LLT)). b. Treated with low-intensity statin (± non-statin LLT) with documentation of intolerance to a moderate or high-intensity statin c. Not receiving statins (± non-statin LLT) with documented evidence of intolerance to any dose of at least 2 different statins with at least one at the lowest approved dose
5. If on any LLTs (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during the participation in the study

Exclusion criteria 4

1. Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria compound heterozygous FH, or double heterozygous FH
2. Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
3. 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
4. Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
2. Number of Participants Who Experience One or More Adverse Events (AEs)
3. Number of Participants Who Discontinue Study Intervention Due to an AE

Secondary endpoints 6

1. Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 52
2. Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (non-HDL-C)
3. Percent Change from Baseline in Apolipoprotein B (ApoB)
4. Percent Change from Baseline in Lipoprotein A [Lp(A)]
5. Percentage of Participants with LDL-C <70 mg/dL and a ≥50% Reduction From Baseline in LDL-C
6. Percentage of Participants with LDL-C <55 mg/dL and a ≥50% Reduction From Baseline in LDL-C

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Elina Mikhailova

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Elina Mikhailova

Third parties 3

Locations

3 EU/EEA countries · 21 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 35 files

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

Application history

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