Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 114
Summary
- Conditions
- Dyslipidemias
- High Cholesterol
- Hypercholesterolemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Placebo-controlled, double-blind, randomizedMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: placebo tablet made to resemble activePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
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 ran...
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.
Tracking Information
- NCT #
- NCT04753606
- Collaborators
- Not Provided
- Investigators
- Not Provided
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