SURMOUNT‐REAL UK: A Pragmatic Randomized Clinical Trial to Assess the Effectiveness of Tirzepatide in Adults With Obesity
10 affiliations
- 1Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health University of Manchester Manchester UK
- 2Diabetes, Endocrinology and Metabolism Centre Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre Manchester UK
- 3Eli Lilly and Company Basingstoke UK
- 4NorthWest EHealth (NWEH) Ltd. Manchester UK
- 5Eli Lilly and Company Indianapolis Indiana USA
- 6Department of Cardiovascular and Metabolic Medicine University of Liverpool Liverpool UK
- 7School of Cardiovascular and Metabolic Health University of Glasgow Glasgow UK
- 8Diabetes Research Centre University of Leicester Leicester UK
- 9NIHR Leicester Biomedical Research Centre Leicester UK
- 10Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health University of Oxford Oxford UK
Abstract
Objective: SURMOUNT‐REAL UK will evaluate the effectiveness of tirzepatide when offered in addition to standard‐of‐care (SoC) in adults with Class I obesity (BMI ≥ 30 and ≤ 34.9 kg/m2) and without diabetes in a UK primary care setting.
Methods: A 5‐year, phase 4, multicenter, open‐label, pragmatic randomized clinical trial is enabled through access to participants' integrated electronic healthcare record data. The study will enroll approximately 3000 participants from Greater Manchester, UK, who are randomly assigned in a 1:1 ratio to receive either tirzepatide and SoC or SoC alone.
Results: The primary endpoint is the percent change in body weight from baseline to Month 24, with the time to onset of type 2 diabetes to Month 60 being the key secondary endpoint. Additional 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.
Conclusions: SURMOUNT‐REAL UK employs a novel study design to evaluate real‐world health outcomes and potential long‐term benefits for both participants and the healthcare system associated with the delivery of pharmacological obesity treatment at a population level. The study is intended to generate critical evidence to support informed decision‐making in obesity management, clinical guideline development, and healthcare policy.
Trial Registration: ClinicalTrials.gov identifier: NCT07247084
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BibTeX
@article{rutter2026surmountreal,
title = {{SURMOUNT‐REAL UK: A Pragmatic Randomized Clinical Trial to Assess the Effectiveness of Tirzepatide in Adults With Obesity}},
author = {Martin K. Rutter and Julie Mount and J. Martin Gibson and Joanne Webb and Cheryl Marler and Catherine Reed and Mugdha Gore and Wenyu Ye and Elisa Gomez Valderas and John Wilding and Naveed Sattar and Melanie J. Davies and Kamlesh Khunti and Richard Haynes and Rachel L. Batterham},
journal = {Obesity (Silver Spring, Md.)},
year = {2026},
month = jun,
doi = {10.1002/oby.70247},
url = {https://doi.org/10.1002/oby.70247},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - SURMOUNT‐REAL UK: A Pragmatic Randomized Clinical Trial to Assess the Effectiveness of Tirzepatide in Adults With Obesity
AU - Martin K. Rutter
AU - Julie Mount
AU - J. Martin Gibson
AU - Joanne Webb
AU - Cheryl Marler
AU - Catherine Reed
AU - Mugdha Gore
AU - Wenyu Ye
AU - Elisa Gomez Valderas
AU - John Wilding
AU - Naveed Sattar
AU - Melanie J. Davies
AU - Kamlesh Khunti
AU - Richard Haynes
AU - Rachel L. Batterham
PY - 2026
DA - 2026/06/15
JO - Obesity (Silver Spring, Md.)
DO - 10.1002/oby.70247
UR - https://doi.org/10.1002/oby.70247
AB - Objective: SURMOUNT‐REAL UK will evaluate the effectiveness of tirzepatide when offered in addition to standard‐of‐care (SoC) in adults with Class I obesity (BMI ≥ 30 and ≤ 34.9 kg/m2) and without diabetes in a UK primary care setting. Methods: A 5‐year, phase 4, multicenter, open‐label, pragmatic randomized clinical trial is enabled through access to participants' integrated electronic healthcare record data. The study will enroll approximately 3000 participants from Greater Manchester, UK, who are randomly assigned in a 1:1 ratio to receive either tirzepatide and SoC or SoC alone. Results: The primary endpoint is the percent change in body weight from baseline to Month 24, with the time to onset of type 2 diabetes to Month 60 being the key secondary endpoint. Additional 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. Conclusions: SURMOUNT‐REAL UK employs a novel study design to evaluate real‐world health outcomes and potential long‐term benefits for both participants and the healthcare system associated with the delivery of pharmacological obesity treatment at a population level. The study is intended to generate critical evidence to support informed decision‐making in obesity management, clinical guideline development, and healthcare policy. Trial Registration: ClinicalTrials.gov identifier: NCT07247084
SN - 1930-7381
SN - 1930-739X
ER -