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

Phase 4 Interventional Eli Lilly and Company · NCT07247084

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

PhasePhase 4
Study typeInterventional
Enrollment3000 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations30 sites (Altrincham and 29 other locations)
Trial IDNCT07247084 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

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions ObesityOverweightElectronic health recordsPrimary careType 2 diabetes incidenceObesity related complicationsPragmatic trialRandomized trial
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.