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

Conditions

• Lipidemia
• Metabolic Syndrome (MetS)
• Type 2 Diabetes (T2DM)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• obicetrapib 10 mg + ezetimibe 10 mg FDC daily — DRUG
  FDC
• Obicetrapib 10 mg — DRUG
  monotherapy
• Placebo — OTHER
  placebo on top of guideline-recommended lipid modifying therapy

Study Details

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 Dates

First listed

Oct 22, 2025

Start date

Dec 11, 2025

Status verified

Sep 2026

Primary completion

Mar 31, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Obicetrapib/Ezetimibe
  obicetrapib 10 mg + ezetimibe 10 mg FDC daily
• Experimental: Obicetrapib
  obicetrapib 10 mg daily
• Placebo Comparator: Placebo
  Placebo on top of guideline-recommended lipid-lowering therapy
• Experimental: Open-Label Extension
  Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg

Primary Outcome Measure

The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group [ Time Frame: 84 days ]

Locations (32)

Find similar trials in Sun City West, AZ

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