Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Part of paid clinical trials in Los Angeles, California.

Sponsor
NewAmsterdam Pharma
Study ID
NCT05266586
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Obicetrapib — DRUG
    tablets
  • Ezetimibe 10mg — DRUG
    capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.
  • Obicetrapib placebo — OTHER
    tablets; no active ingredient
  • Ezetimibe placebo — OTHER
    capsules; no active ingredient

Study Details

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.

Key Dates

Start date
Mar 9, 2022
Status verified
Oct 2022
Primary completion
Aug 12, 2022
Completion
Sep 8, 2022

Study Design

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

Arms

  • Placebo Comparator: Placebo
    once-daily placebo tablet and placebo capsule
  • Experimental: monotherapy
    once-daily obicetrapib 10 mg tablet and placebo capsule
  • Experimental: combination therapy
    once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule

Primary Outcome Measure

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald] [ Time Frame: 12-weeks ]

Locations (16)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research - Westlake d.b.a National Research InstituteLos AngelesCalifornia90057-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
Ocala Cardiovascular ResearchOcalaFlorida34471-
A & R Research Group, LLCPembroke PinesFlorida33024-
Progressive Medical ResearchPort OrangeFlorida32127-
Meridian Clinical Research - Savannah, GASavannahGeorgia31406-
Velocity Clinical ResearchMeridianIdaho83642-
Biofortis, IncAddisonIllinois60101-
Northwest Heart Clinical Research, LLCArlington HeightsIllinois60005-
Midwest Institute for Clinical ResearchIndianapolisIndiana46260-
Research Integrity LLCOwensboroKentucky42303-
Oakland Medical Research CenterTroyMichigan48085-
Mercury Street MedicalButteMontana59701-
Meridian Clinical Research- Springdale, OHCincinnatiOhio45219-
Aventiv Research, Inc.ColumbusOhio43213-
Summit Research Group, LLCMunroe FallsOhio44240-

Find similar trials in Los Angeles, CA

By research site
Velocity Clinical Research - Westlake d.b.a National Research Institute· Los Angeles, CAValley Clinical Trials, Inc.· Northridge, CAOcala Cardiovascular Research· Ocala, FLA & R Research Group, LLC· Pembroke Pines, FLProgressive Medical Research· Port Orange, FLMeridian Clinical Research - Savannah, GA· Savannah, GA

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