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Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days

NCT07614958 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2026-05-29

No results posted yet for this study

Summary

This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy.

The primary objective is to compare the LDL-C lowering effect of OBI (a CETP inhibitor) against BPA at 12 weeks

Conditions

  • Mixed Dyslipidemia
  • Hypercholesterolaemia

Interventions

DRUG

Obicetrapib 10 mg/Bempedoic Acid Placebo

Orally, Once Daily

DRUG

Bempedoic Acid 180mg/Placebo Obicetrapib

Orally, Once Daily

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • A. Menarini International Licensing S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614958 on ClinicalTrials.gov