Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
Part of paid clinical trials in Jonesboro, Arkansas.
- Sponsor
- NewAmsterdam Pharma
- Study ID
- NCT05425745
- Phase
- PHASE3
- Status
- Completed
Conditions
- Dyslipidemias
- Familial Hypercholesterolemia
- Genetic Disease, Inborn
- High Cholesterol
- Hypercholesterolemia
- Hyperlipoproteinemias
- Lipid Metabolism Disorder
- Lipid Metabolism, Inborn Errors
- Metabolic Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Obicetrapib — DRUG10 mg Obicetrapib tablet
- Placebo — DRUGplacebo tablet made to resemble active
Study Details
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).
Key Dates
- Start date
- Jul 25, 2022
- Status verified
- Jun 2025
- Primary completion
- May 28, 2024
- Completion
- May 28, 2024
Study Design
- Enrollment
- 354 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Placeboone placebo tablet once daily
- Experimental: Obicetrapib 10 mgone 10 mg Obicetrapib tablet once daily
Primary Outcome Measure
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] [ Time Frame: 84 Days ]
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site 01022 | Jonesboro | Arkansas | 72401 | - |
| Site 01015 | Toluca Lake | California | 91602 | - |
| Site 01009 | Sarasota | Florida | 34230 | - |
| Site 01023 | Boise | Idaho | 83702 | - |
| Site 01018 | Chicago | Illinois | 60602 | - |
| Site 01012 | Iowa City | Iowa | 52240 | - |
| Site 01007 | Baton Rouge | Louisiana | 70809 | - |
| Site 01005 | Port Gibson | Mississippi | 39105 | - |
| Site 01006 | St Louis | Missouri | 63130 | - |
| Site 01011 | Lincoln | Nebraska | 68510 | - |
| Site 01004 | Norfolk | Nebraska | 68701 | - |
| Site 01002 | Morristown | New Jersey | 07960 | - |
| Site 01010 | New Providence | New Jersey | 07901 | - |
| Site 01001 | North Massapequa | New York | 11758 | - |
| Site 01020 | Morganton | North Carolina | 28655 | - |
| Site 01019 | Winston-Salem | North Carolina | 27157 | - |
| Site 01008 | Chattanooga | Tennessee | 37405 | - |
| Site 01016 | El Paso | Texas | 79905 | - |
| Site 01013 | Houston | Texas | 76706 | - |
| Site 01014 | Suffolk | Virginia | 23434 | - |
Related coverage on Hipa.ai
- Obicetrapib Phase 3 Trial Reduces LDL-C in Heterozygous Familial…Obicetrapib · Jun 11, 2025 · ClinicalTrials.gov
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