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A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504920-25-00
Acronym
MK-0616-018
Enrollment
70
Registered
2024-08-09
Start date
2024-08-23
Completion date
2025-02-27
Last updated
2025-02-20

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

Conditions

Hypercholesterolemia

Brief summary

Mean percent change from baseline in LDL-C at Day 56

Detailed description

Mean percent change from baseline in ApoB at Day 56, Mean percent change from baseline in non-HDL-C at Day 56, Mean percent change from baseline in Lp(a) at Day 56, Percentage of participants who at Day 56 have an LDL-C <70 mg/dL and ≥50% reduction from baseline, Percentage of participants who at Day 56 have an LDL-C<55 mg/dL and ≥50% reduction from baseline, Number of participants with ≥1 adverse event (AE), Number of participants discontinuing from study therapy due to AE

Interventions

DRUGPlacebo for MK-0616
DRUGEZETIMIBE
DRUGBEMPEDOIC ACID

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean percent change from baseline in LDL-C at Day 56

Secondary

MeasureTime frame
Mean percent change from baseline in ApoB at Day 56, Mean percent change from baseline in non-HDL-C at Day 56, Mean percent change from baseline in Lp(a) at Day 56, Percentage of participants who at Day 56 have an LDL-C <70 mg/dL and ≥50% reduction from baseline, Percentage of participants who at Day 56 have an LDL-C<55 mg/dL and ≥50% reduction from baseline, Number of participants with ≥1 adverse event (AE), Number of participants discontinuing from study therapy due to AE

Countries

France, Spain

Outcome results

None listed

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