J3R-MC-YDAG
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants with Obesity or Overweight, without Type 2 Diabetes (ENLIGHTEN-1)
IRAS ID
1013216
Contact name
Lena Mikulski
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
The ENLIGHTEN-1 study is a clinical research project designed to test whether a new investigational medicine can help reduce body weight in people with obesity or those who are overweight and have at least one weight-related health condition. The study also aims to find out if this medicine can delay the development of type 2 diabetes in people with prediabetes. Obesity and overweight are long-term conditions where the body stores too much fat. Many factors can affect body weight, not just diet or activity levels. Lowering body weight may help reduce the risk of certain health problems and improve overall health.
Participants in this study will receive either the investigational medicine or a placebo (a substance with no active medicine). Neither the participants nor the study team will know which treatment each person is receiving. All participants will have access to specialised doctors and researchers, advice on nutrition and physical activity, and regular health checks. The study involves clinic and telehealth visits over a period of about 1 to 3 years, depending on whether the participant has prediabetes and continues to the diabetes prevention extension. During these visits, participants will have health checks, blood and urine tests, and receive support for healthy lifestyle changes. Participants will also be trained to give themselves the study medicine as an injection once a week.
About 1,980 participants will take part in this study, of which approximately 73 will be recruited from the UK. By taking part in this study, participants are helping researchers learn more about potential new treatments for obesity and overweight, which could benefit many people in the future.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
26/EE/0041
Date of REC Opinion
15 Jan 2026
REC opinion
Further Information Favourable Opinion