Sacramento, California 95821

  • Hypercholesterolemia

Purpose:

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.


Study 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. 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.


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


NCT ID:

NCT04753606


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Sacramento, California 95821
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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