FindTrial
Sign In

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502777-42-01
Acronym
MK-0616-013
Enrollment
299
Registered
2023-12-20
Start date
2024-01-16
Completion date
2025-07-14
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

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

Detailed description

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

Interventions

DRUGMicrocrystalline cellulose
DRUGSodium Chloride
DRUGMagnesium Stearate
DRUGMK-0616

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

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

Countries

Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026