Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Last updated: September 18, 2025
Sponsor: NewAmsterdam Pharma
Overall Status: Completed

Phase

3

Condition

High Cholesterol (Hyperlipidemia)

Familial Hypercholesterolemia

Hypercholesterolemia

Treatment

Monotherapy obicetrapib

Combination Therapy placebo

Obicetrapib Placebo

Clinical Study ID

NCT06005597
OBEZ-301
  • Ages > 18
  • All Genders

Study Summary

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors

  • On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestylemodifications

  • LDL-C ≥ 70 mg/dL

  • Triglycerides < 500

  • Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2

Exclusion

Exclusion Criteria:

  • History of New York Heart Association (NYHA) class III or IV heart failure of leftventricular ejection fraction <30%

  • Hospitalized for heart failure within the last 5 years

  • Myocardial infarction, stroke, non-elective coronary revascularization orhospitalization for unstable angina or chest pain in the last 3 months

  • Uncontrolled severe hypertension

  • Diagnosis of homozygous FH

  • Liver disease

  • HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL

  • Thyroid-stimulating hormone >1.5 x upper limit of normal (ULN)

  • History of malignancy

  • Creatinine kinase (CK) >3 X ULN

  • Alcohol abuse

  • Treatment with investigational product

  • Treatment with gemfibrozil or ezetimibe

  • Previous participation in a trial evaluating obicetrapib

  • Known allergy to study drugs, placebo or excipients in study drugs of placebo

  • Other condition that would interfere with the conduct of the study

Study Design

Total Participants: 407
Treatment Group(s): 6
Primary Treatment: Monotherapy obicetrapib
Phase: 3
Study Start date:
March 01, 2024
Estimated Completion Date:
October 16, 2024

Study Description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

Connect with a study center

  • East Valley Diabetes & Endocrinology

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • East Valley Diabetes & Endocrinology

    Gilbert 5295903, Arizona 5551752 85297
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange 4169156, Florida 4155751 32127
    United States

    Site Not Available

  • Centricity Research - Columbus

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Center for Advanced Research and Education

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • NSC Research

    Johns Creek, Georgia 30024
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Centricity Research - Columbus

    Columbus 4188985, Georgia 4197000 31904
    United States

    Site Not Available

  • Center for Advanced Research and Education

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Site Not Available

  • NSC Research

    Johns Creek 6331909, Georgia 4197000 30024
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock 4231874, Georgia 4197000 30189
    United States

    Site Not Available

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Evanston Premier Healthcare Research LLC

    Skokie 4911600, Illinois 4896861 60077
    United States

    Site Not Available

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, Indiana 46321
    United States

    Site Not Available

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster 4924014, Indiana 4921868 46321
    United States

    Site Not Available

  • Grace Research, LLC - Bossier City, LA

    Bossier City, Louisiana 71111
    United States

    Site Not Available

  • Horizon Research Group of Opelousas

    Eunice, Louisiana 70535
    United States

    Site Not Available

  • Grace Research, LLC - Bossier City, LA

    Bossier City 4317639, Louisiana 4331987 71111
    United States

    Site Not Available

  • Horizon Research Group of Opelousas

    Eunice 4323900, Louisiana 4331987 70535
    United States

    Site Not Available

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • TidalHealth Peninsula Regional, Inc.

    Salisbury, Maryland 21804
    United States

    Site Not Available

  • Maryland Cardiovascular Specialists

    Baltimore 4347778, Maryland 4361885 21229
    United States

    Site Not Available

  • TidalHealth Peninsula Regional, Inc.

    Salisbury 4368711, Maryland 4361885 21804
    United States

    Site Not Available

  • McClaren Bay Heart and Vascular

    Bay City, Michigan 49770
    United States

    Site Not Available

  • Northern Pines Health Center

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Oakland Medical Research Center

    Troy, Michigan 48085
    United States

    Site Not Available

  • McClaren Bay Heart and Vascular

    Bay City 4985180, Michigan 5001836 49770
    United States

    Site Not Available

  • Northern Pines Health Center

    Buckley 4987287, Michigan 5001836 49620
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing 4998830, Michigan 5001836 48912
    United States

    Site Not Available

  • Oakland Medical Research Center

    Troy 5012639, Michigan 5001836 48085
    United States

    Site Not Available

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • CentraCare Heart & Vascular Center

    Saint Cloud 5044407, Minnesota 5037779 56303
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo 4448903, Mississippi 4436296 38801
    United States

    Site Not Available

  • St. Louis Heart and Vascular Cardiology

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • St. Louis Heart and Vascular Cardiology

    St Louis 4407066, Missouri 4398678 63136
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63136
    United States

    Site Not Available

  • Triad Internal Medicine

    Asheboro, North Carolina 27203
    United States

    Site Not Available

  • Cary Research Group, LLC

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Novant Health Clinical Research, LLC

    Charlotte, North Carolina 27701
    United States

    Site Not Available

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

    Charlotte, North Carolina 27701
    United States

    Active - Recruiting

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Burke Primary Care

    Morganton, North Carolina 28655
    United States

    Site Not Available

  • Wilmington Health Associates

    Wilmington, North Carolina 28412
    United States

    Site Not Available

  • Triad Internal Medicine

    Asheboro 4453035, North Carolina 4482348 27203
    United States

    Site Not Available

  • Cary Research Group, LLC

    Cary 4459467, North Carolina 4482348 27518
    United States

    Site Not Available

  • Novant Health Clinical Research, LLC

    Charlotte 4460243, North Carolina 4482348 27701
    United States

    Site Not Available

  • Novant Health Heart and Vascular Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Lucas Research, Inc

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Site Not Available

  • Wilmington Health Associates

    Wilmington 4499379, North Carolina 4482348 28412
    United States

    Site Not Available

  • Metabolic and Atherosclerosis Research Center

    Cincinnati, Ohio 45227
    United States

    Site Not Available

  • Summit Research Group, LLC

    Stow, Ohio 44240
    United States

    Site Not Available

  • Metabolic and Atherosclerosis Research Center

    Cincinnati 4508722, Ohio 5165418 45227
    United States

    Site Not Available

  • Summit Research Group, LLC

    Stow 5173171, Ohio 5165418 44240
    United States

    Site Not Available

  • Capital Area Research

    Camp Hill, Pennsylvania 17074
    United States

    Site Not Available

  • Capital Area Research

    Camp Hill 5182928, Pennsylvania 6254927 17074
    United States

    Site Not Available

  • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc

    Rapid City 5768233, South Dakota 5769223 57701
    United States

    Site Not Available

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Cardiovascular Research of Knoxville

    Powell, Tennessee 37849
    United States

    Site Not Available

  • Chattanooga Research & Medicine, PLLC

    Chattanooga 4612862, Tennessee 4662168 37404
    United States

    Site Not Available

  • Cardiovascular Research of Knoxville

    Powell 4651138, Tennessee 4662168 37849
    United States

    Site Not Available

  • Amarillo Heart Clinical Research Institute, Inc

    Amarillo, Texas 79124
    United States

    Site Not Available

  • PharmaTex Research, LLC

    Amarillo, Texas 79109
    United States

    Site Not Available

  • South Texas Clinical Research

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • DM Clinical Research

    Houston, Texas 77375
    United States

    Site Not Available

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Active - Recruiting

  • Juno Research, LLC - Medical Center Office

    Houston, Texas 77054
    United States

    Site Not Available

  • Wellness Clinical Research Associates

    McKinney, Texas 75069
    United States

    Site Not Available

  • Northwest Houston Heart Center

    Tomball, Texas 77375
    United States

    Site Not Available

  • Amarillo Heart Clinical Research Institute, Inc

    Amarillo 5516233, Texas 4736286 79124
    United States

    Site Not Available

  • PharmaTex Research, LLC

    Amarillo 5516233, Texas 4736286 79109
    United States

    Site Not Available

  • South Texas Clinical Research

    Corpus Christi 4683416, Texas 4736286 78404
    United States

    Site Not Available

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth 4691930, Texas 4736286 76132
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • DM Clinical Research

    Houston 4699066, Texas 4736286 77375
    United States

    Site Not Available

  • Juno Research, LLC - Medical Center Office

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Wellness Clinical Research Associates

    McKinney 4710178, Texas 4736286 75069
    United States

    Site Not Available

  • Northwest Houston Heart Center

    Tomball 4737094, Texas 4736286 77375
    United States

    Site Not Available

  • Alpine Research Organization, Inc.

    Clinton, Utah 84015
    United States

    Site Not Available

  • Alpine Research Organization, Inc.

    Clinton 5773001, Utah 5549030 84015
    United States

    Site Not Available

  • Spectrum Medical, Inc.

    Danville, Virginia 24541
    United States

    Site Not Available

  • Hampton Roads Center for Clinical Research

    Suffolk, Virginia 23435
    United States

    Site Not Available

  • Spectrum Medical, Inc.

    Danville 4755280, Virginia 6254928 24541
    United States

    Site Not Available

  • Hampton Roads Center for Clinical Research

    Suffolk 4788158, Virginia 6254928 23435
    United States

    Site Not Available

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