Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Part of paid clinical trials in Anniston, Alabama.

Sponsor
NewAmsterdam Pharma
Study ID
NCT05142722
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    placebo tablet made to resemble active
  • Obicetrapib — DRUG
    10mg obicetrapib tablet

Study Details

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

Key Dates

Start date
Dec 15, 2021
Status verified
Feb 2025
Primary completion
Sep 26, 2024
Completion
Sep 26, 2024

Study Design

Enrollment
2,530 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    one placebo tablet once daily
  • Experimental: obicetrapib 10mg
    one 10mg 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 (69)

FacilityCityStateZIPSite coordinators
Pinnacle Research GroupAnnistonAlabama36207-
Central Alabama ResearchBirminghamAlabama35209-
Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PCBirminghamAlabama35211-
The Center for Clinical Trials, IncSaralandAlabama36571-
Syed Research Consultants, LLCSheffieldAlabama35660-
Clinical Research Institute of Arizona, LLCSun City WestArizona85375-
Eclipse Clinical ResearchTucsonArizona85745-
Synexus Clinical Research US, Inc. / Orange Grove Family PracticeTucsonArizona85741-
American Institute of ResearchBeverly HillsCalifornia90211-
Orange County Research CenterTustinCalifornia92780-
Synexus Clinical Research US, Inc.VistaCalifornia92083-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Pioneer Clinical StudiesFt. PierceFlorida34950-
New Generation of Medical ResearchHialeahFlorida33016-
East Coast Institute for Research, LLCJacksonvilleFlorida32204-
East Coast Institute for Research, LLC - Jacksonville University BlvdJacksonvilleFlorida32216-
East Coast Institute for Research- Lake CityLake CityFlorida32055-
ClinCloud LLCMaitlandFlorida32751-
Columbus Clinical Services, LLCMiamiFlorida33125-
Kendall South Medical Center, Inc.MiamiFlorida33185-
Advanced Research Institute IncNew Port RicheyFlorida34653-
Progressive Medical ResearchPort OrangeFlorida32127-
East Coast Institute for ResearchSaint AugustineFlorida32086-
Synexus Clinical Research US, Inc.The VillagesFlorida32162-
Synexus Clinical Research US, Inc.AtlantaGeorgia30328-
East Coast Institute for Research - CantonCantonGeorgia30114-
Centricity ResearchColumbusGeorgia31904-
East Coast Institute for Research, LLCMaconGeorgia31210-
Alta Pharmaceutical Research CenterPeachtree CornersGeorgia30092-
SouthCoast HealthSavannahGeorgia31406-
Biofortis, IncAddisonIllinois60101-
Evanston Premier Healthcare Research LLCSkokieIllinois60077-
Synexus Clinical Research US, Inc.EvansvilleIndiana47714-
Midwest Institute for Clinical ResearchIndianapolisIndiana46260-
Cotton-O'Neil Clinical Research CenterTopekaKansas66606-
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)LouisvilleKentucky40213-
Research Integrity, LLCOwensboroKentucky42303-
Cambridge Medical TrialsAlexandriaLouisiana71301-
Grace Research, LLCBossier CityLouisiana71111-
Tandem Clinical ResearchMarreroLouisiana70072-
Tandem Clinical Research GI - MetairieMetairieLouisiana70006-
Grace Research, LLCShreveportLouisiana71105-
Southern Clinical Research, LLCZacharyLouisiana70791-
Northern Light CardiologyBangorMaine04401-
Privia Medical Group, LLCSilver SpringMaryland20901-
Arcturus Healthcare, Troy Internal Medicine Research DivisionTroyMichigan48098-
Oakland Medical ResearchTroyMichigan48085-
AB Clinical TrialsLas VegasNevada89119-
Inspira Medical Centers dba Internal Medicine Associates, P.A.BridgetonNew Jersey08302-
Mid Hudson Medical ResearchNew WindsorNew York12553-
Synexus Clinical Research US, Inc.New YorkNew York10017-
Tandem Clinical Research GI, LLCNew YorkNew York10033-
Chear Center LLCThe BronxNew York10455-
Diabetes and Endocrinology Consultants, P.C.Morehead CityNorth Carolina28557-
Lillestol Research, LLCFargoNorth Dakota58104-
Summit Research Group, LLCStowOhio44224-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
Cardiovascular Research of Knoxville, LLCPowellTennessee37849-
Amarillo Heart Clinical Research Institute, IncAmarilloTexas79106-
Inquest Clinical ResearchBaytownTexas77521-
Apex Mobile Clinical ResearchBellaireTexas77401-
Javara Inc.ConroeTexas77384-
Prime Revival Research Institute, LLCCoppellTexas75019-
Thyroid, Endocrinology & Diabetes, PADallasTexas75208-
Northwest Houston Clinical ResearchTomballTexas77375-
Synexus Clinical Research US, Inc.Salt Lake CityUtah84106-
Manassas Clinical Research CenterManassasVirginia20110-
Hampton Roads Center for Clinical ResearchSuffolkVirginia23434-
Universal Research Group, LLCTacomaWashington98405-

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By research site
Pinnacle Research Group· Anniston, ALCentral Alabama Research· Birmingham, ALSynexus Clinical Research US, Inc. / Simon Williamson Clinic, PC· Birmingham, ALThe Center for Clinical Trials, Inc· Saraland, ALSyed Research Consultants, LLC· Sheffield, ALClinical Research Institute of Arizona, LLC· Sun City West, AZ

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