SURMOUNT-REAL UK Trial to Assess Tirzepatide's Effectiveness in Adults with Class I Obesity
Background
Obesity, particularly Class I (BMI 30-34.9 kg/m2), is a growing public health challenge with significant associated comorbidities like type 2 diabetes. Current standard-of-care often involves lifestyle interventions, which can have limited long-term efficacy for substantial weight reduction. Pharmacological treatments, such as tirzepatide, a dual GLP-1R and GIPR agonist, have demonstrated significant weight loss in controlled clinical trials. However, real-world data on its effectiveness, impact on obesity-related complications, and healthcare system implications in a primary care setting are crucial for informing clinical guidelines and policy. This study addresses that gap.
Study Design
The SURMOUNT-REAL UK study is a 5-year, phase 4, multicenter, open-label, pragmatic randomized clinical trial. It will enroll approximately 3000 participants from Greater Manchester, UK, all adults with Class I obesity (BMI ≥ 30 and ≤ 34.9 kg/m2) and without diabetes. Participants will be randomly assigned in a 1:1 ratio to receive either tirzepatide in addition to standard-of-care (SoC) or SoC alone. The study leverages integrated electronic healthcare record data for comprehensive outcome assessment.
Results
This abstract describes the protocol for the SURMOUNT-REAL UK trial, meaning no results are available yet as the study is currently recruiting. The trial is designed to generate critical real-world evidence on tirzepatide's effectiveness. The primary endpoint, to be assessed at Month 24, is: > the percent change in body weight from baseline. The key secondary endpoint will evaluate the time to onset of type 2 diabetes up to Month 60. Additional planned endpoints include the impact of tirzepatide versus SoC on obesity-related complications, health-related quality of life, healthcare resource utilization, productivity, employment, and sickness-related absences. These comprehensive measures aim to provide a holistic view of tirzepatide's benefits beyond just weight loss.
Why It Matters
This pragmatic trial design is crucial for understanding tirzepatide's real-world effectiveness and long-term impact in a primary care setting, moving beyond highly controlled clinical trial environments. The findings will directly inform clinical guideline development and healthcare policy for obesity management in the UK and potentially globally. For peptide users and clinicians, this study will provide valuable insights into the practical application and broader benefits of tirzepatide when integrated into routine care, including its effects on quality of life and healthcare burden. While specific dosing protocols are not detailed here, the study's focus on "standard-of-care" integration suggests a practical approach to treatment delivery.