Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Conditions

• ASCVD
• Dyslipidemias
• Familial Hypercholesterolemia
• High Cholesterol
• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Combination Therapy — COMBINATION_PRODUCT
  tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
• Monotherapy obicetrapib — DRUG
  tablet; 10mg obicetrapib
• Monotherapy ezetimibe — DRUG
  capsule; 10mg ezetimibe
• Combination Therapy placebo — OTHER
  tablet; no active ingredient
• Obicetrapib Placebo — OTHER
  tablet; no active ingredient
• Ezetimibe Placebo — OTHER
  capsule; no active ingredient

Study Details

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

Key Dates

Start date

Mar 1, 2024

Status verified

Sep 2025

Primary completion

Sep 25, 2024

Completion

Oct 16, 2024

Study Design

Enrollment

407 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Combination Therapy
  once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
• Experimental: Monotherapy obicetrapib
  once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
• Active Comparator: Monotherapy ezetimibe
  once-daily ezetimibe 10 mg capsule, 2 placebo tablets
• Placebo Comparator: Placebo
  once-daily placebo tablets (2), placebo capsule

Primary Outcome Measure

Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C [ Time Frame: 84 Days ]

Locations (45)

Related coverage on Hipa.ai

• Obicetrapib/Ezetimibe Combo Reduces LDL-C by 45.58% in Dyslipidemia Trial
  Obicetrapib · Oct 8, 2025 · ClinicalTrials.gov

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