Recruiting

Phase 3

Obicetrapib & EzetimibeA 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

Sponsor:

NewAmsterdam Pharma

Code:

NCT07219602

Conditions

Lipidemia

Type 2 Diabetes (T2DM)

Metabolic Syndrome (MetS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Obicetrapib 10 mg

Placebo

Study Details

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 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.

Conditions

Lipidemia

Type 2 Diabetes (T2DM)

Metabolic Syndrome (MetS)

Study ID

NCT07219602

Start date

Dec 11, 2025

Status verified date

Mar, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

FDC

Obicetrapib 10 mg

monotherapy

Placebo

placebo on top of guideline-recommended lipid modifying therapy

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 ]

Central Contacts and Locations

Central contacts

Gagandeep Dhillon

519-209-2341 Gagandeep.dhillon@fortrea.com

Locations

Clinical Research Institute of Arizona

Recruiting

Sun City West, Arizona, United States, 85375

Scripps Health - Whittier Diabetes Institute

Recruiting

La Jolla, California, United States, 92037

UF Health Jackson

Recruiting

Jacksonville, Florida, United States, 32209

East Coast Institute of Research LLC

Recruiting

Jacksonville, Florida, United States, 32216

East Coast Institute of Research LLC

Recruiting

Lake City, Florida, United States, 32055

Floridian Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Recruiting

Louisville, Kentucky, United States, 40213

MD Medical Research

Recruiting

Oxon Hill, Maryland, United States, 20745

Jefferson City Medical Group

Recruiting

Jefferson City, Missouri, United States, 65109

Montana Medical Research

Recruiting

Missoula, Montana, United States, 59808

Inspira Health - Internal Medicine Associates

Recruiting

Bridgeton, New Jersey, United States, 08302

Central New York Clinical Research

Recruiting

Manlius, New York, United States, 13104

Velocity Clinical Research

Recruiting

Durham, North Carolina, United States, 27710

Floridian Clinical Research

Recruiting

Greensboro, North Carolina, United States, 27408

Centricity Research dba Lucas Research

Recruiting

Morehead City, North Carolina, United States, 28557

Summit Research Group

Recruiting

Munroe Falls, Ohio, United States, 44262

Juno Research LLC - Medical Center

Recruiting

Houston, Texas, United States, 77054

Clinical Trials of Texas dba Flourish Research

Recruiting

San Antonio, Texas, United States, 78229

Burke Internal Medicine

Recruiting

Burke, Virginia, United States, 22015-2234

Burke International Medicine DBA Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

More Information

Sponsor

NewAmsterdam Pharma

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NewAmsterdam Pharma on 2026-03-10.