Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
NewAmsterdam Pharma
Conditions:
Lipidemia
Type 2 Diabetes (T2DM)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ez...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07219602
Start Date
December 1 2025
End Date
June 1 2028
Last Update
December 11 2025
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