Clinical Trials in the USA / NCT07219602
Active, not recruiting
Phase 3
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
Condition(s) studied
LipidemiaType 2 Diabetes (T2DM)Metabolic Syndrome (MetS)
Investigational drug(s) / intervention(s)
obicetrapib 10 mg + ezetimibe 10 mg FDC dailyAll Obicetrapib trials (6) →All Ezetimibe FDC trials (2) →Obicetrapib 10 mg →Placebo
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
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 | Status |
|---|---|---|---|
| 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
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