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

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.

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.

Inclusion Criteria:

• LDL-C > 70 mg/dL and TG < 400 mg/dL,
• Treated with a high-intensity statin therapy

Exclusion Criteria:

• BMI > 40 kg/m
• Significant cardiovascular disease
• HbA1c > 10%
• Uncontrolled hypertension
• Active muscle disease
• GFR < 60 ml/min
• Hepatic dysfunction
• Anemia
• History of malignancy
• Alcohol abuse
• Treatment with investigational product
• Treatment with PCSK9
• Clinically significant condition
• Known CETP inhibitor allergy