NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingPhase 3

Sponsor: NewAmsterdam Pharma

Conditions: Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)

Interventions: obicetrapib 10 mg + ezetimibe 10 mg FDC daily, Obicetrapib 10 mg, Placebo

Countries: United States, Czechia, Netherlands, Slovakia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (55)

Sun City West, Arizona, United States
La Jolla, California, United States
La Jolla, California, United States
Pomona, California, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Lake City, Florida, United States
Maitland, Florida, United States
Miami Lakes, Florida, United States
Sarasota, Florida, United States
Meridian, Idaho, United States
Skokie, Illinois, United States
Louisville, Kentucky, United States
Bangor, Maine, United States
Oxon Hill, Maryland, United States
Jefferson City, Missouri, United States
Missoula, Montana, United States
Bridgeton, New Jersey, United States
Manlius, New York, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Morehead City, North Carolina, United States
Munroe Falls, Ohio, United States
Kingsport, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Burke, Virginia, United States
+ 25 more on CT.gov