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Recruiting NCT07614958

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

Phase III Interventional Mixed Dyslipidemia Hypercholesterolaemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Obicetrapib 10 mg/Bempedoic Acid Placebo, Bempedoic Acid 180mg/Placebo Obicetrapib.
Who it may be relevant to
Registry conditions: Mixed Dyslipidemia, Hypercholesterolaemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Obicetrapib 10 mg/Bempedoic Acid Placebo
    Orally, Once Daily
  • Drug Bempedoic Acid 180mg/Placebo Obicetrapib
    Orally, Once Daily

Primary outcome measures

  • 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. [Time frame: 84 days]
Secondary outcome measures (6)
  • Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group [Time frame: 84 days]
  • Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group; [Time frame: 84 days]
  • Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group; [Time frame: 84 days]
  • Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group; [Time frame: 84 days]
  • Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; [Time frame: 84 days]
  • Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group. [Time frame: 84 days]

Eligibility criteria

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:
  • 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).

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • FutureMeds North Tees — Stockton-on-Tees

Identifiers

NCT: NCT07614958 · AMIL/25/Obi-Dys/001 · 2025-524265-24-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗