A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)
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
2 other identifiers
interventional
3,000
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Nov 2025
Longer than P75 for phase_4 obesity
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2032
April 17, 2026
April 1, 2026
3.6 years
November 19, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, 24 months
Secondary Outcomes (16)
Time from Baseline to Onset of Type 2 Diabetes
Baseline through 60 months
Percentage of Participants Converting from Prediabetes to Normoglycemia
60 months
Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes
60 months
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, 60 months
Percentage of Participants who Develop a New Obesity-Related Complication
60 months
- +11 more secondary outcomes
Study Arms (2)
Tirzepatide + Standard of Care
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC) + standard of care
Standard of Care
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
P91604 St John's Medical Centre
Altrincham, WA14 1PF, United Kingdom
P89008 Ashton Medical Group
Ashton-under-Lyne, OL6 6EW, United Kingdom
Y02319 SSP Bolton General Practice
Bolton, BL1 4TH, United Kingdom
P83012 Tower Family Healthcare
Bury, BL9 0NJ, United Kingdom
P91014 Washway Road Medical Centre
Cheshire, M33 7SS, United Kingdom
P88007 Cheadle Hulme Medical Group (was Cheadle Hulme Health Centre) (Bridge House)
Cheshire, SK8 5LL, United Kingdom
Y02790 SSP Bolton Medical Centre
Great Lever, BL3 6PY, United Kingdom
P89002 The Brooke Surgery
Hyde SK14, SK14 1AT, United Kingdom
P84035 Bodey Medical Centre
Manchester, M14 6WP, United Kingdom
P84630 The Arch Medical Practice
Manchester, M15 5TJ, United Kingdom
P84678 Didsbury Medical Centre
Manchester, M20 2ER, United Kingdom
P84017 Ladybarn Group Practice
Manchester, M20 4SS, United Kingdom
P84068 Chorlton Family Practice
Manchester, M21 9NJ, United Kingdom
P84012 Northenden Group Practice
Manchester, M22 4DH, United Kingdom
P86004 Peterloo Medical Centre
Manchester, M24 4DZ, United Kingdom
P83025 St Gabriels Medical Centre
Manchester, M25 0HT, United Kingdom
P87019 Silverdale Medical Practice
Manchester, M27 8 HP, United Kingdom
P91006 Urmston Group Practice
Manchester, M41 8AA, United Kingdom
P92620 SSP Ince Surgery (Lower Ince)
Manchester, WN3 4NW, United Kingdom
P84034 Barlow Medical Centre
Manchester, United Kingdom
P85010 Woodlands Medical Practice
Oldham, OL9 0LH, United Kingdom
P85011 CH Medical Practice
Oldham, OL9 8NH, United Kingdom
P86022 Stonefield Street Surgery
Rochdale, OL16 4JF, United Kingdom
P91021 Firsway Health Centre
Sale, M33 4BR, United Kingdom
P91013 Boundary House Medical Centre
Sale, United Kingdom
P87027 Langworthy Medical Practice
Salford, M6 5WW, United Kingdom
P88632 Stockport Medical Group
Stockport, SK3 9NX, United Kingdom
P87016 The Sides Medical Centre
Swinton, M27 0EW, United Kingdom
P87025 The Lakes Medical Practice
Swinton, M27 4AF, United Kingdom
Y02322 SSP Leigh Family Practice
Wigen, WN7 2PE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 25, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2032
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.