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 | Recruiting Phase 3

• 2 other identifiers: AMIL/25/Obi-Dys/0012025-524265-24-00
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief 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

Hypercholesterolaemia; Mixed Dyslipidemia

Keywords

Bempedoic Acid; Obicetrapib; Hypercholesterolaemia; Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the percentage change from baseline to Day 84 in LDL-C in the OBI group compared to the BPA group.

  84 days

Secondary Outcomes (6)

• Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group

  84 days

• Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group;

  84 days

• Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group;

  84 days

• Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;

  84 days

• Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group;

  84 days

Study Arms (2)

Obicetrapib

EXPERIMENTAL

Drug: Obicetrapib 10 mg/Bempedoic Acid Placebo

Bempedoic Acid

ACTIVE COMPARATOR

Drug: Bempedoic Acid 180mg/Placebo Obicetrapib

Interventions

Bempedoic Acid 180mg/Placebo Obicetrapib DRUG

Orally, Once Daily

Bempedoic Acid

Obicetrapib 10 mg/Bempedoic Acid Placebo DRUG

Orally, Once Daily

Obicetrapib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are male or female and ≥18 years of age at Screening (Visit 1);
• Females may be enrolled if all 3 of the following criteria are met:
• Are not pregnant;
• Are not breastfeeding; and
• Do not plan to become pregnant during the study.
• Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;
• Are on stable maximally tolerated lipid-modifying therapy for at least 8 weeks prior to Screening (Visit 1) as an adjunct to a lipid-lowering diet and lifestyle modifications, defined as a maximum tolerated statin dose, with or without ezetimibe and/or a monoclonal PCSK9-targeted therapy for at least 4 stable doses prior to Screening (Visit 1);
• Have a fasting serum LDL-C at Screening (Visit 1) of ≥70 mg/dL (1.81 mmol/L) and \<130 mg/dL (3.37 mmol/L);
• Have fasting TGs \<500 mg/dL (\<5.7 mmol/L) at Screening (Visit 1); and
• Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).

You may not qualify if:

• Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction \<30%;
• Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
• Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and/or Hospitalization for unstable angina and/or chest pain.
• Have uncontrolled severe hypertension;
• Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through genetic testing on Dutch Lipid Network criteria, Simon Broome, or MedPed;
• Have active liver disease;
• Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
• Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Screening (Visit 1);
• Have history of full statin intolerance;

Sponsors & Collaborators

• Medpace, Inc.: collaborator
• A. Menarini International Licensing S.A.: lead

Study Sites (1)

FutureMeds North Tees

Stockton-on-Tees, TS19, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Andrea Conte, Medical Doctor

CONTACT

+352 26497650; aconte@menarini.lu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization: Participants are randomized 1:1 to receive either: Group 1: Obicetrapib + Placebo (matching BPA) Group 2: Bempedoic Acid + Placebo (matching OBI)

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-04

Locations

GB (1)