NCT04753606

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to High-Intensity Statin Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.

Detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.

Conditions

• Dyslipidemias
• High Cholesterol
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Obicetrapib	tablets

Timeline

• Start date: 2021-02-18
• Primary completion: 2021-05-24
• Completion: 2021-08-30
• First posted: 2021-02-15
• Last updated: 2024-07-12
• Results posted: 2024-06-11

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study