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NCT07219602PHASE3Recruiting

A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome

NewAmsterdam Pharma

Start Date

12/11/2025

Completion Date

6/1/2028

Summary

This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L) * Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \<400 mg/dL (\<4.5 mmol/L) * Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \<400 mg/dL (\<4.5 mmol/L) and at least 2 risk factors * Are on stable guideline-recommended lipid-lowering therapy * Estimated glomerular filtration rate ≥15 mL/min/1.73 m2 Exclusion Criteria: * Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30% * Have been hospitalized for heart failure within 5 years prior to Screening * Have uncontrolled severe hypertension * Have a formal diagnosis of homozygous familial hypercholesterolemia * HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening * active liver disease

Interventions

DRUG

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

DRUG

Obicetrapib 10 mg

OTHER

Placebo

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Conditions

LipidemiaType 2 Diabetes (T2DM)Metabolic Syndrome (MetS)

Locations

Clinical Research Institute of Arizona

Sun City West, Arizona 85375

United States

Scripps Health - Whittier Diabetes Institute

La Jolla, California 92037

United States

UF Health Jackson

Jacksonville, Florida 32209

United States

East Coast Institute of Research LLC

Jacksonville, Florida 32216

United States

East Coast Institute of Research LLC

Lake City, Florida 32055

United States

Floridian Clinical Research

Miami Lakes, Florida 33016

United States

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky 40213

United States

MD Medical Research

Oxon Hill, Maryland 20745

United States

Jefferson City Medical Group

Jefferson City, Missouri 65109

United States

Montana Medical Research

Missoula, Montana 59808

United States

Inspira Health - Internal Medicine Associates

Bridgeton, New Jersey 08302

United States

Central New York Clinical Research

Manlius, New York 13104

United States

Velocity Clinical Research

Durham, North Carolina 27710

United States

Floridian Clinical Research

Greensboro, North Carolina 27408

United States

Centricity Research dba Lucas Research

Morehead City, North Carolina 28557

United States

Summit Research Group

Munroe Falls, Ohio 44262

United States

Juno Research LLC - Medical Center

Houston, Texas 77054

United States

Clinical Trials of Texas dba Flourish Research

San Antonio, Texas 78229

United States

Burke Internal Medicine

Burke, Virginia 22015-2234

United States

Burke International Medicine DBA Manassas Clinical Research Center

Manassas, Virginia 20110

United States