NewAmsterdam Pharma
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy
Dyslipidemias
High Cholesterol
Hypercholesterolemia
Familial Hypercholesterolemia
Atherosclerotic Cardiovascular Disease
Placebo
Obicetrapib
Phase 3
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying HeFH and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 28 days. Afterwards patients will be randomized to placebo or 10 mg obicetrapib for a 365 day treatment period. After the treatment period, patients will have an end of study follow-up visit.
Study Type : | Interventional |
Estimated Enrollment : | 2532 participants |
Masking: | Quadruple |
Masking Description: | placebo tablet made to resemble active |
Primary Purpose: | Treatment |
Official Title: | A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10mg Obicetrapib in Participants With HeFH and/or ASCVD Who Are Not Adequately Controlled by Their Lipid Modifying Therapies |
Actual Study Start Date : | December 15, 2021 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | September 2024 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo one placebo tablet once daily |
Drug: Placebo |
Experimental: obicetrapib 10mg one 10mg obicetrapib tablet once daily |
Drug: Obicetrapib |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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