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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)

In brief

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.

Key facts

Study ID

NCT07219602

Run by

NewAmsterdam Pharma

People needed

300

Starts

2025-12-11

Expected to finish

2028-06-01

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Institute of Arizona — Sun City West, Arizona, United States (enrolling)
• Scripps Health - Whittier Diabetes Institute — La Jolla, California, United States (enrolling)
• UF Health Jackson — Jacksonville, Florida, United States (enrolling)
• East Coast Institute of Research LLC — Jacksonville, Florida, United States (enrolling)
• East Coast Institute of Research LLC — Lake City, Florida, United States (enrolling)
• Floridian Clinical Research — Miami Lakes, Florida, United States (enrolling)
• Louisville Metabolic and Atherosclerosis Research Center (L-MARC) — Louisville, Kentucky, United States (enrolling)
• MD Medical Research — Oxon Hill, Maryland, United States (enrolling)
• Jefferson City Medical Group — Jefferson City, Missouri, United States (enrolling)
• Montana Medical Research — Missoula, Montana, United States (enrolling)
• Inspira Health - Internal Medicine Associates — Bridgeton, New Jersey, United States (enrolling)
• Central New York Clinical Research — Manlius, New York, United States (enrolling)
• Velocity Clinical Research — Durham, North Carolina, United States (enrolling)
• Floridian Clinical Research — Greensboro, North Carolina, United States (enrolling)
• Centricity Research dba Lucas Research — Morehead City, North Carolina, United States (enrolling)
• Summit Research Group — Munroe Falls, Ohio, United States (enrolling)
• Juno Research LLC - Medical Center — Houston, Texas, United States (enrolling)
• Clinical Trials of Texas dba Flourish Research — San Antonio, Texas, United States (enrolling)
• Burke Internal Medicine — Burke, Virginia, United States (enrolling)
• Burke International Medicine DBA Manassas Clinical Research Center — Manassas, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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