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NCT Number: NCT07247084

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

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.

Recruiting

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

P91604 St John's Medical Centre, Altrincham, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Standard of care

Other

Standard of care

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, 24 months

Secondary outcomes

  1. Time from Baseline to Onset of Type 2 Diabetes

    Time frame: Baseline through 60 months

  2. Percentage of Participants Converting from Prediabetes to Normoglycemia

    Time frame: 60 months

  3. Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes

    Time frame: 60 months

  4. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, 60 months

  5. Percentage of Participants who Develop a New Obesity-Related Complication

    Time frame: 60 months

  6. Change from Baseline in Waist Circumference

    Time frame: Baseline, 60 months

  7. Change from Baseline in Waist-to-Height Ratio

    Time frame: Baseline, 60 months

  8. Change from Baseline in Total Cholesterol

    Time frame: Baseline, 60 months

  9. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, 60 months

  10. Change from Baseline in Diastolic Blood Pressure

    Time frame: Baseline, 60 months

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

    Time frame: Baseline, 60 months

  12. Change from Baseline in EQ-5D-5L

    Time frame: Baseline, 60 months

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

    Time frame: Baseline, 60 months

  14. Change from Baseline in Healthcare Resource Utilization (HCRU)

    Time frame: Baseline, 60 months

  15. Change from Baseline in Alanine Aminotransferase (ALT)

    Time frame: Baseline, 60 months

  16. Change from Baseline in Aspartate Aminotransferase (AST)

    Time frame: Baseline, 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2032
First posted
Nov 25, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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