Is Zenagamtide Safe and Well Tolerated in People with Obesity Who Want to Lose Weight?

This study wants to find out if a new medicine called zenagamtide can help people with obesity lose weight compared to a placebo. We are looking for adults aged 18 to 69 years old who want to lose at least 25% of their body weight to join!


Why this Research Matters

Zengamtide is a new medicine that combines GLP-1 and amylin activity into a single medicine. These are two hormones that naturally work together after you eat, but they affect the body in slightly different ways. Researchers think that this combined treatment may offer greater weight loss benefits. Zengamtide is an investigational drug. This means it has not been approved by the FDA. If you join this study, you will have a visit to make sure you are healthy enough to take part and meet the study requirements. The study team will ask about your health, review your medical history, do a physical exam, check your blood pressure and heart rate, and measure your height and weight. You will give blood samples to help decide if you are a good fit for the study. If you qualify and decide to join, you will be randomly assigned (like the flip of a coin) to one of five doses of zenagamtide or to placebo. A placebo looks like real medicine but does not have any medicine in it. You will take the medicine by mouth every day. Your dose will slowly go up every 4 weeks until you reach the target dose. During the study, you will have regular blood tests, electrocardiograms to check your heart, and health measurements. You will also fill out questionnaires. You will meet with a registered dietitian at each visit to talk about your diet and exercise. Study visits will occur every 4 weeks. The visits will be in-person for the first 6 months and then will alternate between in-person and by phone after that. When treatment ends, you will have one final phone visit about four weeks later and one final in-person visit eight weeks later. You will have 16 in-person visits and 7 phone visits during the study. The whole study will last about 84 weeks (about 1 year and 8 months). The study medicine will be provided at no cost to you. You can earn up to $2,350 if you complete all study visits. You may be able to get reimbursed for travel expenses.


Who can Participate

Adult

To join this study, you must be between 18 to 69 years old, have a BMI of 30 or higher and have a desire to lose at least 25% of your 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.


Study ID

Protocol Number: 26-1319


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Daniel Bessesen, MD

Principal Investigator