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

NCT ID: NCT05266586

Last Updated: 2024-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2022-09-08

Brief Summary

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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.

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Detailed Description

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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. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

Conditions

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Dyslipidemias High Cholesterol Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo-controlled, double-blind, randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
placebo tablet made to resemble active; placebo capsule made to resemble active

Study Groups

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Placebo

once-daily placebo tablet and placebo capsule

Group Type PLACEBO_COMPARATOR

Obicetrapib placebo

Intervention Type OTHER

tablets; no active ingredient

Ezetimibe placebo

Intervention Type OTHER

capsules; no active ingredient

monotherapy

once-daily obicetrapib 10 mg tablet and placebo capsule

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

tablets

Ezetimibe placebo

Intervention Type OTHER

capsules; no active ingredient

combination therapy

once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

tablets

Ezetimibe 10mg

Intervention Type DRUG

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

Interventions

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Obicetrapib

tablets

Intervention Type DRUG

Ezetimibe 10mg

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

Intervention Type DRUG

Obicetrapib placebo

tablets; no active ingredient

Intervention Type OTHER

Ezetimibe placebo

capsules; no active ingredient

Intervention Type OTHER

Other Intervention Names

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CETP inhibitor

Eligibility Criteria

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Inclusion Criteria

* LDL-C \> 70 mg/dL and Triglycerides \< 400 mg/dL,
* Treated with a high-intensity statin therapy

Exclusion Criteria

* BMI \>= 40 kg/m2
* Significant cardiovascular disease
* HbA1c \>= 10%
* Uncontrolled hypertension
* Active muscle disease
* estimated glomerular filtration rate \< 60 mL/min
* Hepatic dysfunction
* History of participation in any clinical trial evaluating obicetrapib
* Anemia
* History of malignancy
* Alcohol abuse
* Treatment with investigational product
* Treatment with PCSK9
* Clinically significant condition
* Known CETP inhibitor allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NewAmsterdam Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Ditmarsch

Role: STUDY_DIRECTOR

NewAmsterdam Pharma

Locations

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Velocity Clinical Research - Westlake d.b.a National Research Institute

Los Angeles, California, United States

Site Status

Valley Clinical Trials, Inc.

Northridge, California, United States

Site Status

Ocala Cardiovascular Research

Ocala, Florida, United States

Site Status

A & R Research Group, LLC

Pembroke Pines, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Meridian Clinical Research - Savannah, GA

Savannah, Georgia, United States

Site Status

Velocity Clinical Research

Meridian, Idaho, United States

Site Status

Biofortis, Inc

Addison, Illinois, United States

Site Status

Northwest Heart Clinical Research, LLC

Arlington Heights, Illinois, United States

Site Status

Midwest Institute for Clinical Research

Indianapolis, Indiana, United States

Site Status

Research Integrity LLC

Owensboro, Kentucky, United States

Site Status

Oakland Medical Research Center

Troy, Michigan, United States

Site Status

Mercury Street Medical

Butte, Montana, United States

Site Status

Meridian Clinical Research- Springdale, OH

Cincinnati, Ohio, United States

Site Status

Aventiv Research, Inc.

Columbus, Ohio, United States

Site Status

Summit Research Group, LLC

Munroe Falls, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TA-8995-202

Identifier Type: -

Identifier Source: org_study_id

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