IRB Study Number 23-751
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Digestive Disease & Surgery Institute
Description
Study is being conducted to determine the effectiveness of an investigational medication (retatrutide). Retatrutide is an investigational (experimental) drug that is not approved by the Food and Drug Administration (FDA). Investigational means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the FDA. The FDA is allowing the use of this drug for research.
In comparison to placebo, the primary purpose of this study is to investigate the effects of retatrutide on weight loss outcomes. A placebo is a solution that looks like the study drug but has no medicine. If you are eligible, you will be randomly assigned, like the flip of a coin, to receive retatrutide or placebo.
As a study participant, you will receive lifestyle counseling by a research fellow or Dr. Butsch. Lifestyle counseling will consist of advice on healthy food choices. You will also set physical activity goals. Diet and physical activity goals established during the lifestyle consultations and adherence to the lifestyle component of the trial will be expected.
Your participation in the research will last about 2 years. For a couple of months, the study treatment period may continue beyond 2 years until all the information needed by researchers has been collected.
If you have been diagnosed with a heart attack, stroke, or peripheral arterial disease, you may qualify for the study. For the study, we are enrolling patients who are diagnosed with obesity alone or type 2 diabetes and obesity. Additional criteria are listed below.
Inclusion Criteria
Specific criteria for patients diagnosed with obesity:
- Body mass index (BMI) of ++>++35 kg/m².
- Weight stability over the past 90 days.
- Over the past 90 days, not taking medications or supplements for weight loss.
- Self-classification as African American, Asian, Native Hawaiian, Pacific Islander, or American Indian.
Specific criteria for patients diagnosed with type 2 diabetes:
HbA1c of ++>++6.5% but ++<++10.5%.
Body mass index (BMI) of ++>++35 kg/m².
Weight stability over the past 90 days.
- Stable treatment for type 2 diabetes for at least the prior 90 days.
- Potential participants may be taking medications such as metformin, glipizide, glimepiride, glyburide, canagliflozin, dapagliflozin, empagliflozin, rosiglitazone, and pioglitazone to manage their type 2 diabetes.
- Basal insulin (night or morning time insulin) is permitted.
