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New treatment option for Lipidemia
Official title 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
ClinicalTrials.gov ID: NCT07219602
What this study is testing
What is obicetrapib 10 mg + ezetimibe 10 mg FDC daily?
obicetrapib 10 mg + ezetimibe 10 mg FDC daily is an investigational medicine, being studied as a potential treatment for lipidemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Are on stable guideline-recommended lipid-lowering therapy
- Estimated glomerular filtration rate ≥15 mL/min/1.73 m2
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sun City West, Arizona, United States
- La Jolla, California, United States
- Jacksonville, Florida, United States
- Lake City, Florida, United States
- Miami Lakes, Florida, United States
- Louisville, Kentucky, 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
- Greensboro, North Carolina, United States
- Morehead City, North Carolina, United States
- Munroe Falls, Ohio, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Burke, Virginia, United States
- Manassas, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sun City West, Arizona, United States; La Jolla, California, United States; Jacksonville, Florida, United States; Lake City, Florida, United States; Miami Lakes, Florida, United States; Louisville, Kentucky, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.