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

Phase 4RecruitingNCT07247084

Eli Lilly and Company3,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

3,000

Conditions

Obesity

Interventions

TirzepatideDRUG

Administered SC

Standard of CareOTHER

Standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

Outcomes

Primary Outcomes

Percent Change from Baseline in Body Weight

Time frame: Baseline, 24 months

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)