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 (MEDICI)

A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on Top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk

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

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolaemia; Mixed Dyslipidemia
• Intervention / Treatment: Drug: Obicetrapib 10 mg/Bempedoic Acid Placebo; Drug: Bempedoic Acid 180mg/Placebo Obicetrapib

• Study Type: Interventional
• Enrollment (Estimated): 426
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Andrea Conte, Medical Doctor; Phone Number: +352 26497650; Email: aconte@menarini.lu

Study Locations

• United Kingdom
  • Stockton-on-Tees, United Kingdom, TS19
    • Recruiting
    • FutureMeds North Tees

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. Are not pregnant;
  2. Are not breastfeeding; and
  3. 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).

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obicetrapib	Drug: Obicetrapib 10 mg/Bempedoic Acid Placebo; Orally, Once Daily
Active Comparator: Bempedoic Acid	Drug: Bempedoic Acid 180mg/Placebo Obicetrapib; Orally, Once Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Secondary Endpoints	Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group;; Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group;; Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group;; Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;; Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; and; Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group.	84 days

Collaborators and Investigators

• Sponsor: A. Menarini International Licensing S.A.
• Collaborators: Medpace, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mixed Dyslipidemia; Obicetrapib; Hypercholesterolaemia; Bempedoic Acid
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
• Other Study ID Numbers: AMIL/25/Obi-Dys/001; 2025-524265-24-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No