Tirzepatide versus usual care for adults with obesity (no diabetes) in UK primary care
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
This study will test whether tirzepatide helps adults with obesity who do not have diabetes lose weight and lower their chance of developing type 2 diabetes compared with standard care in UK primary care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 30 sites (Altrincham and 29 other locations) |
| Trial ID | NCT07247084 on ClinicalTrials.gov |
What this trial studies
This phase 4 interventional study will enroll adults with obesity but without diabetes and compare treatment with tirzepatide to standard of care over about 260 weeks in a real-world primary care setting. Participants must have BMI 30–34.9 kg/m2, an elevated waist-to-height ratio (>0.5), at least one weight-related comorbidity, and a prior attempt at lifestyle weight loss; people with any form of diabetes or recent large weight change are excluded. The trial will use data from participating UK primary care practices and electronic health records to track body weight changes and new diagnoses of type 2 diabetes. Outcomes aim to reflect effectiveness and safety of tirzepatide when used alongside routine clinical care.
Who should consider this trial
Good fit: Adults without diabetes who have BMI 30–34.9, waist-to-height ratio >0.5, at least one weight-related comorbidity, and who have tried lifestyle measures to lose weight are the intended participants.
Not a fit: People who already have type 1 or type 2 diabetes, those with recent large weight changes, or individuals with contraindications to tirzepatide are unlikely to benefit from this study's intervention.
Why it matters
Potential benefit: If successful, tirzepatide could provide sustained weight loss and reduce the risk of developing type 2 diabetes for people with obesity who do not yet have diabetes.
How similar studies have performed: Prior phase 3 SURMOUNT trials showed substantial weight loss with tirzepatide in people with obesity, and this study tests whether those results translate into routine primary care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Have type 1 diabetes, type 2 diabetes, or any other types of diabetes * Have had a change in body weight of greater than 5 kilograms (11 pounds) within 90 days prior to screening
Where this trial is running
Altrincham and 29 other locations
- P91604 St John's Medical Centre — Altrincham, United Kingdom (Not_yet_recruiting)
- P89008 Ashton Medical Group — Ashton-under-Lyne, United Kingdom (Recruiting)
- Y02319 SSP Bolton General Practice — Bolton, United Kingdom (Not_yet_recruiting)
- P83012 Tower Family Healthcare — Bury, United Kingdom (Not_yet_recruiting)
- P91014 Washway Road Medical Centre — Cheshire, United Kingdom (Not_yet_recruiting)
- P88007 Cheadle Hulme Medical Group (was Cheadle Hulme Health Centre) (Bridge House) — Cheshire, United Kingdom (Not_yet_recruiting)
- Y02790 SSP Bolton Medical Centre — Great Lever, United Kingdom (Not_yet_recruiting)
- P89002 The Brooke Surgery — Hyde SK14, United Kingdom (Recruiting)
- P84035 Bodey Medical Centre — Manchester, United Kingdom (Recruiting)
- P84630 The Arch Medical Practice — Manchester, United Kingdom (Recruiting)
- P84678 Didsbury Medical Centre — Manchester, United Kingdom (Not_yet_recruiting)
- P84017 Ladybarn Group Practice — Manchester, United Kingdom (Not_yet_recruiting)
- P84068 Chorlton Family Practice — Manchester, United Kingdom (Not_yet_recruiting)
- P84012 Northenden Group Practice — Manchester, United Kingdom (Not_yet_recruiting)
- P86004 Peterloo Medical Centre — Manchester, United Kingdom (Recruiting)
- P83025 St Gabriels Medical Centre — Manchester, United Kingdom (Not_yet_recruiting)
- P87019 Silverdale Medical Practice — Manchester, United Kingdom (Recruiting)
- P91006 Urmston Group Practice — Manchester, United Kingdom (Not_yet_recruiting)
- P92620 SSP Ince Surgery (Lower Ince) — Manchester, United Kingdom (Not_yet_recruiting)
- P84034 Barlow Medical Centre — Manchester, United Kingdom (Not_yet_recruiting)
- P85010 Woodlands Medical Practice — Oldham, United Kingdom (Recruiting)
- P85011 CH Medical Practice — Oldham, United Kingdom (Recruiting)
- P86022 Stonefield Street Surgery — Rochdale, United Kingdom (Recruiting)
- P91021 Firsway Health Centre — Sale, United Kingdom (Not_yet_recruiting)
- P91013 Boundary House Medical Centre — Sale, United Kingdom (Not_yet_recruiting)
- P87027 Langworthy Medical Practice — Salford, United Kingdom (Recruiting)
- P88632 Stockport Medical Group — Stockport, United Kingdom (Not_yet_recruiting)
- P87016 The Sides Medical Centre — Swinton, United Kingdom (Recruiting)
- P87025 The Lakes Medical Practice — Swinton, United Kingdom (Recruiting)
- Y02322 SSP Leigh Family Practice — Wigen, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.