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Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT05142722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2530

Last updated 2025-09-19

Study results available
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Summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy

Conditions

Interventions

DRUG

Placebo

placebo tablet made to resemble active

DRUG

Obicetrapib

10mg obicetrapib tablet

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
2021-12-15
Primary Completion
2024-09-26
Completion
2024-09-26
FDA Drug
Yes

Countries

  • United States
  • China
  • Czechia
  • Denmark
  • Georgia
  • Japan
  • Netherlands
  • Poland

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 NCT05142722 on ClinicalTrials.gov