Randomized Study of Obicetrapib in Combination With Ezetimibe

Part of paid clinical trials in Lincoln, California.

Sponsor
NewAmsterdam Pharma
Study ID
NCT04770389
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Obicetrapib 5mg — DRUG
    tablet
  • Ezetimibe 10mg — DRUG
    tablet
  • Placebo — OTHER
    tablet

Study Details

This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.

Key Dates

Start date
Feb 23, 2021
Status verified
Mar 2024
Primary completion
May 7, 2021
Completion
Jun 30, 2021

Study Design

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

Arms

  • Placebo Comparator: Placebo
    placebo obicetrapib + placebo ezetimibe; once daily
  • Experimental: Combination therapy
    5 mg obicetrapib + 10 mg ezetimibe; once daily
  • Experimental: Obicetrapib monotherapy
    5 mg obicetrapib + placebo ezetimibe; once daily
  • Experimental: Ezetimibe monotherapy
    placebo obicetrapib + 10 mg ezetimibe; once daily

Primary Outcome Measure

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] [ Time Frame: 8 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Trials ResearchLincolnCalifornia95648-
Evanston Premier Healthcare Research LLCEvanstonIllinois60201-
Juno Research, LLC - Medical Center OfficeHoustonTexas77054-

Find similar trials in Lincoln, CA

By research site
Clinical Trials Research· Lincoln, CAEvanston Premier Healthcare Research LLC· Evanston, ILJuno Research, LLC - Medical Center Office· Houston, TX

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