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

• Status: Not yet recruiting
• Trial end date: 2022-08-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewAmsterdam Pharma
• Treatments: Ezetimibe

Criteria

Inclusion Criteria:

• LDL-C > 70 mg/dL and Triglycerides < 400 mg/dL,

• Treated with a high-intensity statin therapy

Exclusion Criteria:

• BMI >= 40 kg/m2

• Significant cardiovascular disease

• HbA1c >= 10%

• Uncontrolled hypertension

• Active muscle disease

• estimated glomerular filtration rate < 60 mL/min

• Hepatic dysfunction

• History of participation in any clinical trial evaluating obicetrapib

• Anemia

• History of malignancy

• Alcohol abuse

• Treatment with investigational product

• Treatment with PCSK9

• Clinically significant condition

• Known CETP inhibitor allergy