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Recruiting NCT07247084

A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)

Phase IV Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide, Standard of Care.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Tirzepatide
    Administered SC
  • Other Standard of Care
    Standard of care

Primary outcome measures

  • Percent Change from Baseline in Body Weight [Time frame: Baseline, 24 months]
Secondary outcome measures (12)
  • Time from Baseline to Onset of Type 2 Diabetes [Time frame: Baseline through 60 months]
  • Percentage of Participants Converting from Prediabetes to Normoglycemia [Time frame: 60 months]
  • Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes [Time frame: 60 months]
  • Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, 60 months]
  • Percentage of Participants who Develop a New Obesity-Related Complication [Time frame: 60 months]
  • Change from Baseline in Waist Circumference [Time frame: Baseline, 60 months]
  • Change from Baseline in Waist-to-Height Ratio [Time frame: Baseline, 60 months]
  • Change from Baseline in Total Cholesterol [Time frame: Baseline, 60 months]
  • Change from Baseline in Systolic Blood Pressure [Time frame: Baseline, 60 months]
  • Change from Baseline in Diastolic Blood Pressure [Time frame: Baseline, 60 months]
  • Percent Change from Baseline Urinary Albumin-to-Creatinine Ratio (UACR) [Time frame: Baseline, 60 months]
  • Change from Baseline in EQ-5D-5L [Time frame: Baseline, 60 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 30 centers
  • P91604 St John's Medical Centre — Altrincham
  • P89008 Ashton Medical Group — Ashton-under-Lyne
  • Y02319 SSP Bolton General Practice — Bolton
  • P83012 Tower Family Healthcare — Bury
  • P91014 Washway Road Medical Centre — Cheshire
  • P88007 Cheadle Hulme Medical Group (was Cheadle Hulme Health Centre) (Bridge House) — Cheshire
  • Y02790 SSP Bolton Medical Centre — Great Lever
  • P89002 The Brooke Surgery — Hyde SK14
  • … and 22 more centers

Publications

  • Rutter MK, Mount J, Gibson JM, Webb J, Marler C, Reed C, Gore M, Ye W, Gomez Valderas E, Wilding J, Sattar N, Davies MJ, Khunti K, Haynes R, Batterham RL. SURMOUNT-REAL UK: A Pragmatic Randomized Clinical Trial to Assess the Effectiveness of Tirzepatide in Adults With Obesity. Obesity (Silver Spring). 2026 Jun 15. doi: 10.1002/oby.70247. Online ahead of print. PMID 42297568

Identifiers

NCT: NCT07247084 · 27331 · I8F-MC-GPJF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗