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Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

NCT05425745 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2025-06-11

Study results available
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Summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

Conditions

  • Dyslipidemias
  • High Cholesterol
  • Hypercholesterolemia
  • Familial Hypercholesterolemia
  • Lipid Metabolism Disorder
  • Metabolic Disease
  • Lipid Metabolism, Inborn Errors
  • Genetic Disease, Inborn
  • Hyperlipoproteinemias

Interventions

DRUG

Obicetrapib

10 mg Obicetrapib tablet

DRUG

Placebo

placebo tablet made to resemble active

Sponsors & Collaborators

  • NewAmsterdam Pharma

    lead INDUSTRY

Principal Investigators

  • Marc Ditmarsch · NewAmsterdam Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2024-05-28
Completion
2024-05-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Georgia
  • Netherlands
  • Norway
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425745 on ClinicalTrials.gov