Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Part of paid clinical trials in Anniston, Alabama.

Sponsor
NewAmsterdam Pharma
Study ID
NCT04753606
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 18, 2021
Status verified
Sep 2021
Primary completion
May 24, 2021
Completion
Aug 30, 2021

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    once-daily placebo
  • Experimental: obicetrapib 5 mg
    once-daily obicetrapib
  • Experimental: obicetrapib 10 mg
    once-daily obicetrapib

Primary Outcome Measure

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] [ Time Frame: 8-weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
Pinnacle Research GroupAnnistonAlabama36207-
National Research Institute - Huntington ParkHuntington ParkCalifornia90255-
National Research Institute - WilshireLos AngelesCalifornia90057-
Clinical Trials ResearchSacramentoCalifornia95821-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Ocala Cardiovascular ResearchOcalaFlorida34474-
Progressive Medical ResearchPort OrangeFlorida32127-
IACT HealthColumbusGeorgia31904-
Evanston Premier Healthcare Research LLCEvanstonIllinois60201-
Midwest Institute for Clinical ResearchIndianapolisIndiana46260-
Oakland Medical Research CenterTroyMichigan48085-
Diabetes and Endocrinology Consultants, P.C.Morehead CityNorth Carolina28557-
Lillestol Research, LLCFargoNorth Dakota58104-
Metabolic and Atherosclerosis Research CenterCincinnatiOhio45227-
Summit Research Group, LLCMunroe FallsOhio44262-
Health ConceptsRapid CitySouth Dakota57702-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
Juno Research, LLHoustonTexas77040-
Manassas Clinical Research CenterManassasVirginia20110-

Find similar trials in Anniston, AL

Related Studies