This study is testing a new medicine called zenagamtide to see if it can help people with obesity to lose weight better than a placebo (a treatment that looks like the real medicine but does not contain any active drug).
If you join this study, you will help researchers find out if a new medicine called zenagamtide can help people with obesity lose weight. The study will compare five different doses of zenagamtide to a placebo. A placebo looks like real medicine but does not have any medicine in it. Approximately 79% of the participants will get zenagamtide. Before you start treatment, the study team will check to make sure you are healthy enough and meet the study rules at a screening visit. They will ask about your health and medical history, do a physical exam and will check your blood pressure and pulse. They will measure your height and weight. You will give blood samples for screening laboratory tests. These tests help decide if you can continue in the study. If you can continue, you will be randomly assigned (like the flip of a coin) to one of five doses of zenagamtide or to placebo (a tablet that looks like the medicine but has no active drug) taken by mouth on a daily basis. Your dose will slowly go up every 4 weeks until you reach the target dose. During the study, you will have regular blood tests, ECGs (electrocardiograms to check your heart), measurements, and questionnaires. Study visits will occur every 4 weeks (in-person for the first 6 months and then alternating between in-person and by phone after that). You will meet with a registered dietitian at each visit for dietary counseling. When treatment ends, you will have one final phone visit about four weeks later and one final in-person visit eight weeks later for the final tests. The whole study will last about 84 weeks (about 1 year and 8 months).
To join this study, you must be between 18 – 69 years old, have a BMI of 30 or higher and a desire to lose at least 25% of their body weight. 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: 26-1319
Principal Investigator