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Looking for participantsPhase3

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

Sponsor: A. Menarini International Licensing S.A.

NCT ID: NCT07614958

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Obicetrapib 10 mg/Bempedoic Acid Placebo (drug), Bempedoic Acid 180mg/Placebo Obicetrapib (drug)
How long the study runs
Study runs about 8 months (dates as stated)
About the drug or intervention
Obicetrapib 10 mg/Bempedoic Acid Placebo — drug: Orally, Once Daily · Bempedoic Acid 180mg/Placebo Obicetrapib — drug: Orally, Once Daily
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
426
Started
2026-05-06
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for mixed dyslipidemia
  • • Phase3 - 426 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with mixed dyslipidemia

Where?

  • • Stockton-on-Tees - FutureMeds North Tees

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Mixed DyslipidemiaHypercholesterolaemia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

meteGFR

What the study is looking for

  • ✓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.

Who cannot take part

  • ✗Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection...
  • ✗Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to...
  • ✗Have uncontrolled severe hypertension;
  • ✗Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through...
  • ✗Have active liver disease;
See the full 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: 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;

Where Is This Study? (1 UK site)

FutureMeds North Tees

Stockton-on-Tees TS19, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nth-tr.ntandh.researchdevelopment@nhs.net01642 624090

How to Get in Touch

Andrea Conte, Medical Doctor

Sponsor contact

CONTACT

+352 26497650 aconte@menarini.lu
Data sourced from ClinicalTrials.gov · Last verified: 2026-04