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

April 16, 2026 updated by: Eli Lilly and Company

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • United Kingdom
      • Altrincham, United Kingdom, WA14 1PF
        • Not yet recruiting
        • P91604 St John's Medical Centre
        • Principal Investigator:
          • Lorna McCune
      • Ashton-under-Lyne, United Kingdom, OL6 6EW
        • Recruiting
        • P89008 Ashton Medical Group
        • Principal Investigator:
          • Omair Razzaq
      • Bolton, United Kingdom, BL1 4TH
        • Not yet recruiting
        • Y02319 SSP Bolton General Practice
        • Principal Investigator:
          • Naheed Khan
      • Bury, United Kingdom, BL9 0NJ
        • Not yet recruiting
        • P83012 Tower Family Healthcare
        • Principal Investigator:
          • Karishma Singh
      • Cheshire, United Kingdom, M33 7SS
        • Not yet recruiting
        • P91014 Washway Road Medical Centre
        • Principal Investigator:
          • Helen Wilkinson
      • Cheshire, United Kingdom, SK8 5LL
        • Not yet recruiting
        • P88007 Cheadle Hulme Medical Group (was Cheadle Hulme Health Centre) (Bridge House)
        • Principal Investigator:
          • Keith Richardson
      • Great Lever, United Kingdom, BL3 6PY
        • Not yet recruiting
        • Y02790 SSP Bolton Medical Centre
        • Principal Investigator:
          • Naheed Khan
      • Hyde SK14, United Kingdom, SK14 1AT
        • Recruiting
        • P89002 The Brooke Surgery
        • Principal Investigator:
          • Nabeel Arshad
      • Manchester, United Kingdom, M24 4DZ
        • Recruiting
        • P86004 Peterloo Medical Centre
        • Principal Investigator:
          • Imran Ghafoor
      • Manchester, United Kingdom, M41 8AA
        • Not yet recruiting
        • P91006 Urmston Group Practice
        • Principal Investigator:
          • Cliff Tong
      • Manchester, United Kingdom, WN3 4NW
        • Not yet recruiting
        • P92620 SSP Ince Surgery (Lower Ince)
        • Principal Investigator:
          • Kavi Saraswathi
      • Manchester, United Kingdom, M27 8 HP
        • Recruiting
        • P87019 Silverdale Medical Practice
        • Principal Investigator:
          • Mitesh Sharma
      • Manchester, United Kingdom, M21 9NJ
        • Not yet recruiting
        • P84068 Chorlton Family Practice
        • Principal Investigator:
          • Katy Burns
      • Manchester, United Kingdom, M20 4SS
        • Not yet recruiting
        • P84017 Ladybarn Group Practice
        • Principal Investigator:
          • Clare Murray Brown
      • Manchester, United Kingdom, M14 6WP
        • Recruiting
        • P84035 Bodey Medical Centre
        • Principal Investigator:
          • Stephen Tomkinson
      • Manchester, United Kingdom, M15 5TJ
        • Recruiting
        • P84630 The Arch Medical Practice
        • Principal Investigator:
          • Steven Colabella
      • Manchester, United Kingdom, M20 2ER
        • Not yet recruiting
        • P84678 Didsbury Medical Centre
        • Principal Investigator:
          • Andrew Coupes
      • Manchester, United Kingdom, M22 4DH
        • Not yet recruiting
        • P84012 Northenden Group Practice
        • Principal Investigator:
          • Naresh Kanumili
      • Manchester, United Kingdom, M25 0HT
        • Not yet recruiting
        • P83025 St Gabriels Medical Centre
        • Principal Investigator:
          • Richard Deacon
      • Manchester, United Kingdom
        • Not yet recruiting
        • P84034 Barlow Medical Centre
        • Principal Investigator:
          • Eidn Mahmoudzadeh
      • Oldham, United Kingdom, OL9 0LH
        • Recruiting
        • P85010 Woodlands Medical Practice
        • Principal Investigator:
          • Daniel Thompson
      • Oldham, United Kingdom, OL9 8NH
        • Recruiting
        • P85011 CH Medical Practice
        • Principal Investigator:
          • Naseem Gil
      • Rochdale, United Kingdom, OL16 4JF
        • Recruiting
        • P86022 Stonefield Street Surgery
        • Principal Investigator:
          • Usman Ahmed
      • Sale, United Kingdom, M33 4BR
        • Not yet recruiting
        • P91021 Firsway Health Centre
        • Principal Investigator:
          • Grainne Breen
      • Sale, United Kingdom
        • Not yet recruiting
        • P91013 Boundary House Medical Centre
        • Principal Investigator:
          • Zakariya Goga
      • Salford, United Kingdom, M6 5WW
        • Recruiting
        • P87027 Langworthy Medical Practice
        • Principal Investigator:
          • Benjamin Brown
      • Stockport, United Kingdom, SK3 9NX
        • Not yet recruiting
        • P88632 Stockport Medical Group
        • Principal Investigator:
          • Sophie Tudor-Jones
      • Swinton, United Kingdom, M27 0EW
        • Recruiting
        • P87016 The Sides Medical Centre
        • Principal Investigator:
          • Laurence Cribbin
      • Swinton, United Kingdom, M27 4AF
        • Recruiting
        • P87025 The Lakes Medical Practice
        • Principal Investigator:
          • Jazin Salim
      • Wigen, United Kingdom, WN7 2PE
        • Not yet recruiting
        • Y02322 SSP Leigh Family Practice
        • Principal Investigator:
          • Kavi Saraswathi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Other: Standard of Care
Standard of care
Experimental: Tirzepatide + Standard of Care
Participants will receive tirzepatide subcutaneously (SC) + standard of care
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, 24 months
Baseline, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from Baseline to Onset of Type 2 Diabetes
Time Frame: Baseline through 60 months
Baseline through 60 months
Percentage of Participants Converting from Prediabetes to Normoglycemia
Time Frame: 60 months
60 months
Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes
Time Frame: 60 months
60 months
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 60 months
Baseline, 60 months
Percentage of Participants who Develop a New Obesity-Related Complication
Time Frame: 60 months
60 months
Change from Baseline in Waist Circumference
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Waist-to-Height Ratio
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Total Cholesterol
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Systolic Blood Pressure
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Diastolic Blood Pressure
Time Frame: Baseline, 60 months
Baseline, 60 months
Percent Change from Baseline Urinary Albumin-to-Creatinine Ratio (UACR)
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in EQ-5D-5L
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-lite-CT)
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Healthcare Resource Utilization (HCRU)
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Alanine Aminotransferase (ALT)
Time Frame: Baseline, 60 months
Baseline, 60 months
Change from Baseline in Aspartate Aminotransferase (AST)
Time Frame: Baseline, 60 months
Baseline, 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27331
  • I8F-MC-GPJF (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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