Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

• Status: Completed
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

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.

• 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 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