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

NCT05266586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-07-03

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Obicetrapib

tablets

DRUG

Ezetimibe 10mg

capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

OTHER

Obicetrapib placebo

tablets; no active ingredient

OTHER

Ezetimibe placebo

capsules; no active ingredient

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
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2022-08-12
Completion
2022-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05266586 on ClinicalTrials.gov