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
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
Interventions
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Obicetrapib 10 mg
Placebo
Conditions
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