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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521495-54-00
Acronym
MK-0616-037
Enrollment
110
Registered
2025-11-19
Start date
2025-12-20
Completion date
Unknown
Last updated
2025-12-04

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

Conditions

Hyperlipidemia

Brief summary

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

Detailed description

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

Interventions

DRUGMK-0616 (Enlicitide chloride) Placebo
DRUGROSUVASTATIN

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

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

Secondary

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

Countries

Hungary, Spain

Outcome results

None listed

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