This study is testing a new medicine called Retatrutide to see if it can help people with obesity lose weight, and if it works better than a placebo (a treatment that looks like the real medicine but does not contain any active drug) to help keep weight off.
If you join this study, you will help researchers find out if a new medicine called Retatrutide can help people with obesity lose weight and keep it off. The study will compare Retatrutide to a placebo. A placebo looks like real medicine but does not have any medicine in it. Before you start treatment, the study team will check to make sure you are healthy enough and meet the study rules. They will ask about your health and family history, what you eat, and will check your blood pressure and pulse. They will measure your height, weight, and waist size. You will give blood and urine samples. A DXA scan will be done to measure your body fat and muscle. These tests help decide if you can continue in the study. If you can continue, you will get weekly shots of Retatrutide under your skin. Your dose will slowly go up every 4 weeks during the first 16 weeks until you reach the full dose or the highest dose you can handle. This will last about 80 weeks (almost 2 years). After that, you will be randomly given either the same dose, a lower dose, or a placebo shot that looks like the medicine but has no active drug. You will not know which one you get. During both parts of the study, you will have regular blood tests, DXA scans, and ECGs to check your health. When treatment ends, you will have one final visit about four weeks later for the last tests. The whole study will last about 125 weeks (almost 2 and a half years).
To join this study, you must be at least 18 years old and have a BMI of 35 or higher. You should not have type 1 or type 2 diabetes. You also must not have used any weight loss medications in the past three months, and you must not have used any GLP-1 medications in the past 12 months.
Protocol Number: 24-2526
Principal Investigator