A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: NewAmsterdam Pharma

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

BMI > or =35 kg/m2 Significant cardiovascular disease HbA1c > 10% Uncontrolled hypertension Active muscle disease GFR < 60 ml/min Hepatic dysfunction Anemia Existing CETP deficiency History of Homozygous Familial Hypercholerstrolemia History of malignancy Alcohol abuse Treatment with investigational product Treatment with PCSK9 Clinically significant condition Known CETP inhibitor allergy