SURMOUNT-REAL UK: A Pragmatic Randomized Clinical Trial to Assess the Effectiveness of Tirzepatide in Adults With Obesity.
Martin K Rutter, Julie Mount, J Martin Gibson...
https://pubmed.ncbi.nlm.nih.gov/42297568/Actively Recruiting
Led by Eli Lilly and Company · Updated on 2026-07-07
3000
Participants Needed
30
Research Sites
156 weeks
Total Duration
Researchers are evaluating tirzepatide in adults with obesity who do not have diabetes but have at least one weight-related health condition. The study aims to assess body weight loss and the development of type 2 diabetes over a long period in a real-world setting. This is a Phase 4 clinical trial sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either weekly subcutaneous injections of tirzepatide in addition to standard care or standard care alone. The study uses a parallel design to compare these two groups and lasts about 260 weeks 5 years. The focus is on long-term effects and real-world treatment outcomes. During the study, participants will have regular assessments including measurements of body weight, blood sugar control HbA1c, waist circumference, blood pressure, cholesterol, kidney function, quality of life, and healthcare resource use. The primary outcome is the percent change in body weight from baseline to 24 months. Secondary outcomes cover diabetes onset, metabolic changes, obesity-related complications, and quality of life over 60 months. Participants will be monitored throughout the study duration for safety and health changes.
CONDITIONS
A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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Eli Lilly and Company
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 260 weeks (5 years)
Participants receive weekly tirzepatide injections along with standard care or standard care alone.
Regular study visits for assessments
Duration - Up to 60 months
Participants are monitored for long-term health outcomes including body weight changes and incidence of type 2 diabetes.
Periodic health assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Martin K Rutter, Julie Mount, J Martin Gibson...
https://pubmed.ncbi.nlm.nih.gov/42297568/Eli Lilly and Company
Lead Sponsor