Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dyslipidemias, High Cholesterol, Hypercholesterolemia

Intervention / Treatment
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* Drug: Obicetrapib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo-controlled, double-blind, randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>once-daily placebo | Drug: Obicetrapib<br>* tablets<br>* Other names: CETP inhibitor;|
| Experimental: obicetrapib 5 mg<br>once-daily obicetrapib | Drug: Obicetrapib<br>* tablets<br>* Other names: CETP inhibitor;|
| Experimental: obicetrapib 10 mg<br>once-daily obicetrapib | Drug: Obicetrapib<br>* tablets<br>* Other names: CETP inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C | Percent change in LDL-C | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoB | Percent change in ApoB | 8-weeks | 
| Non-HDL-C | Percent change in Non-HDL-C | 8-weeks | 
| HDL-C | Percent change in HDL-C | 8-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obicetrapib, statin, LDL-C, cholesterol, atherosclerosis