A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable 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 in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable 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 stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 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 visit.

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 Stable Statin Therapy in Japanese Subjects.

Conditions
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Dyslipidemia, Hypercholesterolemia, High Cholesterol

Intervention / Treatment
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* Drug: Obicetrapib
* 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 stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20 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

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>* No active ingredient<br>* Other names: placebo tablet;|
| Experimental: Experimental 2.5 mg Obicetrapib<br>once-daily Obicetrapib | Drug: Obicetrapib<br>* tablet<br>* Other names: CETP inhibitor;|
| Experimental: Experimental 5 mg Obicetrapib<br>once-daily Obicetrapib | Drug: Obicetrapib<br>* tablet<br>* Other names: CETP inhibitor;|
| Experimental: Experimental 10 mg Obicetrapib<br>once-daily Obicetrapib | Drug: Obicetrapib<br>* tablet<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 |
| --- | --- | --- |
| Apo B | percent change in Apo B | 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 cholestero, l atherosclerosis