NCT05425745

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (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 to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

Detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with HeFH 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 to placebo or 10 mg obicetrapib for an 365-day treatment period. After the treatment period, participants will have an end-of-study follow-up visit.

Conditions

• Dyslipidemias
• High Cholesterol
• Hypercholesterolemia
• Familial Hypercholesterolemia
• Lipid Metabolism Disorder
• Metabolic Disease
• Lipid Metabolism, Inborn Errors
• Genetic Disease, Inborn
• Hyperlipoproteinemias

Interventions

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

Timeline

• Start date: 2022-07-25
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2022-06-21
• Last updated: 2025-06-11
• Results posted: 2025-06-11

Locations

96 sites across 10 countries: United States, Canada, Czechia, Georgia, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study