A Phase 4 Multicenter, Randomized, Open-Label, Interventional Study With Pragmatic Elements Investigating the Effectiveness of Tirzepatide Once Weekly Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes in a Real-World Setting
NCT: NCT07247084 ·
Status: RECRUITING ·
Phase: Phase 4
· Sponsor: Eli Lilly and Company
· Started: 2025-11-24
· Est. Completion: 2032-07
Official Summary
The purpose of this study is to evaluate tirzepatide within a real-world setting to assess body weight loss and incidence of type 2 diabetes in adults without diabetes who have obesity and at least one weight-related comorbid condition. Participation in the study will last about 260 weeks.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 3,000 participants
Interventions
- DRUG: Tirzepatide — Administered SC
- OTHER: Standard of Care — Standard of care
Primary Outcomes
- Percent Change from Baseline in Body Weight (Baseline, 24 months)
Secondary Outcomes
- Time from Baseline to Onset of Type 2 Diabetes (Baseline through 60 months)
- Percentage of Participants Converting from Prediabetes to Normoglycemia (60 months)
- Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes (60 months)
- Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, 60 months)
- Percentage of Participants who Develop a New Obesity-Related Complication (60 months)
Trial Locations
- P91604 St John's Medical Centre, Altrincham, United Kingdom
- P89008 Ashton Medical Group, Ashton-under-Lyne, United Kingdom
- Y02319 SSP Bolton General Practice, Bolton, United Kingdom
- P83012 Tower Family Healthcare, Bury, United Kingdom
- P91014 Washway Road Medical Centre, Cheshire, United Kingdom
- P88007 Cheadle Hulme Medical Group (was Cheadle Hulme Health Centre) (Bridge House), Cheshire, United Kingdom
- Y02790 SSP Bolton Medical Centre, Great Lever, United Kingdom
- P89002 The Brooke Surgery, Hyde SK14, United Kingdom
- P84035 Bodey Medical Centre, Manchester, United Kingdom
- P84630 The Arch Medical Practice, Manchester, United Kingdom
- ...and 10 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.