A Randomized Phase 3 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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

June 30, 2028

Conditions
LipidemiaType 2 Diabetes (T2DM)Metabolic Syndrome (MetS)
Interventions
DRUG

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

FDC

DRUG

Obicetrapib 10 mg

monotherapy

OTHER

Placebo

placebo on top of guideline-recommended lipid modifying therapy

Sponsors
All Listed Sponsors
lead

NewAmsterdam Pharma

INDUSTRY