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
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have a body mass index ≥30 and ≤34.9 kilogram per square meter (kg/m2)
• Have an increased waist to height ratio (defined by \>0.5)
• Have at least one weight related comorbid condition
• Have had at least one attempt to lose weight with lifestyle intervention (diet and physical activity)
Locations
Other Locations
United Kingdom
P91604 St John's Medical Centre
NOT_YET_RECRUITING
Altrincham
P89008 Ashton Medical Group
RECRUITING
Ashton-under-lyne
Y02319 SSP Bolton General Practice
NOT_YET_RECRUITING
Bolton
P83012 Tower Family Healthcare
NOT_YET_RECRUITING
Bury
P88007 Cheadle Hulme Medical Group (was Cheadle Hulme Health Centre) (Bridge House)
NOT_YET_RECRUITING
Cheshire
P91014 Washway Road Medical Centre
NOT_YET_RECRUITING
Cheshire
Y02790 SSP Bolton Medical Centre
NOT_YET_RECRUITING
Great Lever
P89002 The Brooke Surgery
RECRUITING
Hyde Sk14
P84035 Bodey Medical Centre
NOT_YET_RECRUITING
Manchester
P84046 Cheetham Hill Medical Centre
NOT_YET_RECRUITING
Manchester
P84630 The Arch Medical Practice
NOT_YET_RECRUITING
Manchester
P86004 Peterloo Medical Centre
RECRUITING
Manchester
P87019 Silverdale Medical Practice
RECRUITING
Manchester
P91006 Urmston Group Practice
NOT_YET_RECRUITING
Manchester
P92620 SSP Ince Surgery (Lower Ince)
NOT_YET_RECRUITING
Manchester
P85010 Woodlands Medical Practice
NOT_YET_RECRUITING
Oldham
P85011 CH Medical Practice
NOT_YET_RECRUITING
Oldham
P86022 Stonefield Street Surgery
RECRUITING
Rochdale
P91021 Firsway Health Centre
NOT_YET_RECRUITING
Sale
P87027 Langworthy Medical Practice
RECRUITING
Salford
P88632 Stockport Medical Group
NOT_YET_RECRUITING
Stockport
P87016 The Sides Medical Centre
RECRUITING
Swinton
P87025 The Lakes Medical Practice
RECRUITING
Swinton
Y02322 SSP Leigh Family Practice
NOT_YET_RECRUITING
Wigen
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2032-07
Participants
Target number of participants: 3000
Treatments
Experimental: Tirzepatide + Standard of Care
Participants will receive tirzepatide subcutaneously (SC) + standard of care
Active_comparator: Standard of Care
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company