NCT05266586

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (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 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.

Detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, 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, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

Conditions

• Dyslipidemias
• High Cholesterol
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Obicetrapib	tablets
DRUG	Ezetimibe 10mg	capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.
OTHER	Obicetrapib placebo	tablets; no active ingredient
OTHER	Ezetimibe placebo	capsules; no active ingredient

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-08-12
• Completion: 2022-09-08
• First posted: 2022-03-04
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study