A Phase 4 Multicenter, Randomized, Open-Label Study Comparing Weekly Tirzepatide Injections With Standard of Care in Adults With Obesity Without Diabetes in a Real-World Setting

What this Trial Is About

Researchers are evaluating tirzepatide in adults with obesity but without diabetes to study its effects on weight loss and the development of type 2 diabetes in a real-world setting. This phase 4 study compares tirzepatide combined with standard care against standard care alone, focusing on body weight changes and diabetes incidence over several years. Participants will be randomly assigned to receive either weekly subcutaneous injections of tirzepatide plus standard care or standard care alone. The study will last about 260 weeks 5 years, with key measurements taken at baseline, 24 months, and up to 60 months. Outcomes include changes in body weight, onset of type 2 diabetes, glycemic control, waist measurements, cholesterol, blood pressure, kidney function, quality of life, and healthcare resource use. During the study, participants will undergo regular assessments of weight, blood tests including hemoglobin A1c, blood pressure, and other health indicators. Researchers will monitor diabetes development and obesity-related complications, as well as the impact on quality of life. Safety and effectiveness data will be collected throughout the long-term follow-up, helping to understand tirzepatides role in managing obesity without diabetes.

A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)