Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS 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 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, 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 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, 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, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

Official Title
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A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study

Conditions
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Dyslipidemias, High Cholesterol, Hypercholesterolemia

Intervention / Treatment
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* Drug: Obicetrapib
* Drug: Ezetimibe 10mg
* Other: Obicetrapib placebo
* Other: Ezetimibe placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL-C > 70 mg/dL and Triglycerides < 400 mg/dL, Treated with a high-intensity statin therapy Exclusion Criteria: BMI >= 40 kg/m2 Significant cardiovascular disease HbA1c >= 10% Uncontrolled hypertension Active muscle disease estimated glomerular filtration rate < 60 mL/min Hepatic dysfunction History of participation in any clinical trial evaluating obicetrapib 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 tablet and placebo capsule | Other: Obicetrapib placebo<br>* tablets; no active ingredient<br>Other: Ezetimibe placebo<br>* capsules; no active ingredient<br>|
| Experimental: monotherapy<br>once-daily obicetrapib 10 mg tablet and placebo capsule | Drug: Obicetrapib<br>* tablets<br>* Other names: CETP inhibitor;Other: Ezetimibe placebo<br>* capsules; no active ingredient<br>|
| Experimental: combination therapy<br>once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule | Drug: Obicetrapib<br>* tablets<br>* Other names: CETP inhibitor;Drug: Ezetimibe 10mg<br>* capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of combination therapy compared with placebo on LDL-C | Percent change in LDL-C | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of obicetrapib 10 mg monotherapy compared with placebo on LDL-C | Percent change in LDL-C | 12-weeks | 
| Effect combination therapy compared with placebo on ApoB | Percent change in ApoB | 12-weeks | 
| Effect obicetrapib 10 mg monotherapy compared with placebo on ApoB | Percent change in ApoB | 12-weeks | 

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