NCT06005597

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

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will be 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 as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-25
• Completion: 2024-10-16
• First posted: 2023-08-22
• Last updated: 2025-10-08
• Results posted: 2025-10-08

Locations

45 sites across 1 country: United States

Regulatory

• FDA-regulated drug study