NCT05142722

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10mg Obicetrapib in Participants With HeFH and/or ASCVD Who Are Not Adequately Controlled by Their Lipid Modifying Therapies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,530 (actual)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib 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 underlying HeFH and/or ASCVD 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 28 days. Afterwards patients will be randomized to placebo or 10 mg obicetrapib for a 365 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

Conditions

• Dyslipidemias
• High Cholesterol
• Hypercholesterolemia
• Familial Hypercholesterolemia
• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Placebo	placebo tablet made to resemble active
DRUG	Obicetrapib	10mg obicetrapib tablet

Timeline

• Start date: 2021-12-15
• Primary completion: 2024-09-26
• Completion: 2024-09-26
• First posted: 2021-12-03
• Last updated: 2025-09-19
• Results posted: 2025-09-19

Locations

181 sites across 8 countries: United States, China, Czechia, Denmark, Georgia, Japan, Netherlands, Poland

Regulatory

• FDA-regulated drug study