A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Sponsor
NewAmsterdam Pharma
Study ID
NCT05421078
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Obicetrapib — DRUG
    tablet
  • Placebo — DRUG
    No active ingredient

Study Details

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.

Key Dates

Start date
Jun 27, 2022
Status verified
Sep 2024
Primary completion
Mar 24, 2023
Completion
Apr 21, 2023

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Once-daily placebo
  • Experimental: 2.5 mg Obicetrapib
    once-daily Obicetrapib
  • Experimental: 5 mg Obicetrapib
    once-daily Obicetrapib
  • Experimental: 10 mg Obicetrapib
    once-daily Obicetrapib

Primary Outcome Measure

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

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