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

Lilly

Status and phase: Enrolling; Phase 4

Conditions: Obesity

Treatments: Drug: Tirzepatide; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT07247084

I8F-MC-GPJF (Other Identifier)

27331

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Tirzepatide + Standard of Care

Experimental group

Description:

Participants will receive tirzepatide subcutaneously (SC) + standard of care

Treatment:

Drug: Tirzepatide

Standard of Care

Active Comparator group

Treatment:

Other: Standard of Care