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

NCT07219602 · tracked via the Priya Life Science USA tracker

Sponsor

NewAmsterdam Pharma

Phase

Phase 3

Started

2025-12-11

Last updated

2026-09-09

Condition(s) studied

LipidemiaType 2 Diabetes (T2DM)Metabolic Syndrome (MetS)

Investigational drug(s) / intervention(s)

obicetrapib 10 mg + ezetimibe 10 mg FDC dailyObicetrapib 10 mgPlacebo

obicetrapib 10 mg + ezetimibe 10 mg FDC daily: FDC

Obicetrapib 10 mg: monotherapy

Placebo: placebo on top of guideline-recommended lipid modifying therapy

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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 — 84 days

Trial sites (55)

Facility	City	Region
Clinical Research Institute of Arizona	Sun City West	Arizona
Scripps Health - Whittier Diabetes Institute	La Jolla	California
UC SanDiego Health	La Jolla	California
Western University of Health Sciences	Pomona	California
UF Health Jackson	Jacksonville	Florida
East Coast Institute of Research LLC	Jacksonville	Florida
East Coast Institute of Research LLC	Lake City	Florida
K2 Medical Research	Maitland	Florida
Floridian Clinical Research	Miami Lakes	Florida
Cardiovascular Center of Sarasote Foundation for Research and Education	Sarasota	Florida
High Desert Heart	Meridian	Idaho
Endeavour Health	Skokie	Illinois
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)	Louisville	Kentucky
Eastern Maine Medical Center	Bangor	Maine
MD Medical Research	Oxon Hill	Maryland
Jefferson City Medical Group	Jefferson City	Missouri
Montana Medical Research	Missoula	Montana
Inspira Health - Internal Medicine Associates	Bridgeton	New Jersey
Central New York Clinical Research	Manlius	New York
Duke University Medical Center	Durham	North Carolina
Velocity Clinical Research	Durham	North Carolina
PharmQuest Life Sciences, LLC	Greensboro	North Carolina
Centricity Research dba Lucas Research	Morehead City	North Carolina
Summit Research Group	Munroe Falls	Ohio
Diabetes & Glandular Disease Clinic, P.A.	Kingsport	Tennessee
Baylor College of Medicine - Center for Cardiometabolic Disease Prevention (The Center for Cardiovascular Disease Prevention)	Houston	Texas
Juno Research LLC - Medical Center	Houston	Texas
PlanIt Research, PLLC	Houston	Texas
Clinical Trials of Texas dba Flourish Research	San Antonio	Texas
Burke Internal Medicine	Burke	Virginia
Burke International Medicine DBA Manassas Clinical Research Center	Manassas	Virginia
Universal Research Group	Tacoma	Washington
Dien Servis s.r.o.	Humpolec	Vysocina
DOCTOR MN s.r.o	Čáslav	Czechia
MUDr. Alena Váchová	České Budějovice	Czechia
MEDIKA Hradec Králové, s.r.o.	Hradec Králové	Czechia
Interni diabetologicka ambulance (Pratia)	Jílové u Prahy	Czechia
Diabetologie - Dr. Tomas Edelsberger	Krnov	Czechia
Pratia Pardubice a.s. (Pratia)	Pardubice	Czechia
Dieko s.r.o	Pilsen	Czechia

+ 15 more sites — see the full list on the official registry below.

More NewAmsterdam Pharma trials in the USA

Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers Recruiting

Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels Recruiting

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease Active, not recruiting

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque Active, not recruiting

Investigating the Effect of Obicetrapib on Lipoprotein Metabolism Active, not recruiting

Other trials for the same condition

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219602 on ClinicalTrials.gov ↗ ← All trials in the USA