ObesityPhase 4NCT07247084
A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)
A Phase 4 study testing Tirzepatide in people with Obesity, run by Eli Lilly and Company at 30 sites in United Kingdom.
Trial 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. Eligible participants must be registered patients at a participating site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 30 sitesUnited Kingdom
- Study dates
- 24 Nov 2025to Jul 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
30 sites in 1 country
United Kingdom30 sites, 30 recruiting
- Not yet recruiting
P91604 St John's Medical Centre
Altrincham, WA14 1PF
- Recruiting
P89008 Ashton Medical Group
Ashton-under-Lyne, OL6 6EW
- Not yet recruiting
Y02319 SSP Bolton General Practice
Bolton, BL1 4TH
- Not yet recruiting
P83012 Tower Family Healthcare
Bury, BL9 0NJ
- Not yet recruiting
P91014 Washway Road Medical Centre
Cheshire, M33 7SS
- Not yet recruiting
P88007 Cheadle Hulme Medical Group (was Cheadle Hulme Health Centre) (Bridge House)
Cheshire, SK8 5LL
- Not yet recruiting
Y02790 SSP Bolton Medical Centre
Great Lever, BL3 6PY
- Recruiting
P89002 The Brooke Surgery
Hyde SK14, SK14 1AT
- Recruiting
P84035 Bodey Medical Centre
Manchester, M14 6WP
- Recruiting
P84630 The Arch Medical Practice
Manchester, M15 5TJ
- Not yet recruiting
P84678 Didsbury Medical Centre
Manchester, M20 2ER
- Not yet recruiting
P84017 Ladybarn Group Practice
Manchester, M20 4SS
- Not yet recruiting
P84068 Chorlton Family Practice
Manchester, M21 9NJ
- Not yet recruiting
P84012 Northenden Group Practice
Manchester, M22 4DH
- Recruiting
P86004 Peterloo Medical Centre
Manchester, M24 4DZ
- Not yet recruiting
P83025 St Gabriels Medical Centre
Manchester, M25 0HT
- Recruiting
P87019 Silverdale Medical Practice
Manchester, M27 8 HP
- Not yet recruiting
P91006 Urmston Group Practice
Manchester, M41 8AA
- Not yet recruiting
P92620 SSP Ince Surgery (Lower Ince)
Manchester, WN3 4NW
- Not yet recruiting
P84034 Barlow Medical Centre
Manchester
- Recruiting
P85010 Woodlands Medical Practice
Oldham, OL9 0LH
- Recruiting
P85011 CH Medical Practice
Oldham, OL9 8NH
- Recruiting
P86022 Stonefield Street Surgery
Rochdale, OL16 4JF
- Not yet recruiting
P91021 Firsway Health Centre
Sale, M33 4BR
- Not yet recruiting
P91013 Boundary House Medical Centre
Sale
- Recruiting
P87027 Langworthy Medical Practice
Salford, M6 5WW
- Not yet recruiting
P88632 Stockport Medical Group
Stockport, SK3 9NX
- Recruiting
P87016 The Sides Medical Centre
Swinton, M27 0EW
- Recruiting
P87025 The Lakes Medical Practice
Swinton, M27 4AF
- Not yet recruiting
Y02322 SSP Leigh Family Practice
Wigen, WN7 2PE
About this study
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
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.
Eligible participants must be registered patients at a participating site. Participation in the study will last about 260 weeks.
- Conditions
- Obesity
- Being tested
- Tirzepatide, Standard of Care
- Keywords
- Overweight, Electronic health records, Primary care, Type 2 diabetes incidence, Obesity related complications, Pragmatic trial, Randomized trial
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
Standard of CareOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide + Standard of Care | Experimental | Participants will receive tirzepatide subcutaneously (SC) + standard of care Receives: Drug: Tirzepatide |
| Standard of Care | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Measured: Baseline, 24 months
Secondary outcomes (16)
Time from Baseline to Onset of Type 2 Diabetes
Measured: Baseline through 60 months
Percentage of Participants Converting from Prediabetes to Normoglycemia
Measured: 60 months
Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes
Measured: 60 months
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, 60 months
Percentage of Participants who Develop a New Obesity-Related Complication
Measured: 60 months
Change from Baseline in Waist Circumference
Measured: Baseline, 60 months
Change from Baseline in Waist-to-Height Ratio
Measured: Baseline, 60 months
Change from Baseline in Total Cholesterol
Measured: Baseline, 60 months
Change from Baseline in Systolic Blood Pressure
Measured: Baseline, 60 months
Change from Baseline in Diastolic Blood Pressure
Measured: Baseline, 60 months
Percent Change from Baseline Urinary Albumin-to-Creatinine Ratio (UACR)
Measured: Baseline, 60 months
Change from Baseline in EQ-5D-5L
Measured: Baseline, 60 months
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-lite-CT)
Measured: Baseline, 60 months
Change from Baseline in Healthcare Resource Utilization (HCRU)
Measured: Baseline, 60 months
Change from Baseline in Alanine Aminotransferase (ALT)
Measured: Baseline, 60 months
Change from Baseline in Aspartate Aminotransferase (AST)
Measured: Baseline, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start24 Nov 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247084
- Sponsor's protocol ID
- 27331
- Other IDs
- I8F-MC-GPJF
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 42297568
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07247084
- Acronym / sponsor ID
- 27331
- Conditions
- Obesity
- Keywords
- Overweight, Electronic health records, Primary care, Type 2 diabetes incidence, Obesity related complications, Pragmatic trial, Randomized trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Eligible participants must be registered patients at a participating site. Participation in the study will last about 260 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide + Standard of Care | Experimental | Drug: TirzepatideParticipants will receive tirzepatide subcutaneously (SC) + standard of care |
| Standard of Care | Active comparator | Other: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide + Standard of Care |
| Standard of CareStandard of care | Other | Standard of Care |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, 24 months
16 secondary outcomes
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
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-lite-CT)
Time frame: Baseline, 60 months
Change from Baseline in Healthcare Resource Utilization (HCRU)
Time frame: Baseline, 60 months
Change from Baseline in Alanine Aminotransferase (ALT)
Time frame: Baseline, 60 months
Change from Baseline in Aspartate Aminotransferase (AST)
Time frame: Baseline, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 42297568Rutter 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Obesity, run by Eli Lilly and Company at 30 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Body Weight (time frame: Baseline, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07247084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.