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RecruitingPhase 4

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

30

Recruiting sites

12

Enrollment

3,000

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI 30-34.9

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07247084
Org study ID27331
Secondary IDI8F-MC-GPJFEli Lilly and Company

Timeline

Milestones

Study start2025-11-24actual
Study first posted2025-11-25actual
Last update posted2026-04-17actual
Primary completion2029-07estimated (month precision)
Study completion2032-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
4
Weight & body composition
3
Cardiometabolic biomarkers
3
MASH / liver
2
Patient-reported / QoL
2
Renal / kidney
1
Other clinical outcomes
1
Other (unclassified)
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, 24 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, 60 months

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist-to-Height Ratio

Time frame:Baseline, 60 months

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Time from Baseline to Onset of Type 2 Diabetes

Time frame:Baseline through 60 months

Time to T2DM onset

time to event, event

Secondary/protocol endpoint/low confidence

Percentage of Participants Converting from Prediabetes to Normoglycemia

Time frame:60 months

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes

Time frame:60 months

threshold achievement, event

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 60 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Alanine Aminotransferase (ALT)

Time frame:Baseline, 60 months

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change from Baseline in Aspartate Aminotransferase (AST)

Time frame:Baseline, 60 months

AST, change

change from baseline, improvement

LOINC 1920-8

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline Urinary Albumin-to-Creatinine Ratio (UACR)

Time frame:Baseline, 60 months

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change from Baseline in Total Cholesterol

Time frame:Baseline, 60 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure

Time frame:Baseline, 60 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure

Time frame:Baseline, 60 months

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change from Baseline in EQ-5D-5L

Time frame:Baseline, 60 months

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-lite-CT)

Time frame:Baseline, 60 months

IWQOL-Lite total

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Percentage of Participants who Develop a New Obesity-Related Complication

Time frame:60 months

threshold achievement, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from Baseline in Healthcare Resource Utilization (HCRU)

Time frame:Baseline, 60 months

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.