SURMOUNT-5
Research type
Research Study
Full title
A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide 2.4 mg in Adults Who Have Obesity or Overweight with Weight-Related Comorbidities (SURMOUNT-5)
IRAS ID
1006492
Contact name
Ola Khaled
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
Obesity is a chronic disease and its increasing prevalence is a public health concern associated with rising incidence of type 2 diabetes, increased risk for premature death, and increased risk for some cancers. Although weight loss has been shown to reduce complications related to obesity and improve quality of life, lifestyle therapies fail to achieve sustainable weight loss in the majority of patients with obesity. Therefore, there is increasing recognition that complementary therapies are required in addition to lifestyle changes for patients with obesity to achieve and maintain weight loss to improve health outcomes.
Tirzepatide is a single medicine that is a GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like-peptide-1) receptor agonist. It acts similar to GIP and GLP-1 (natural hormones in the body) and appears to regulate appetite as a study demonstrated reduced food intake and improved apetite.
Semaglutide is a GLP-1 (glucagon-like-peptide-1) receptor agonist. It acts in the same way as GLP-1 (a natural hormone in the body) and appears to regulate appetite by increasing a person’s feelings of fullness, while reducing their food intake, hunger and cravings.
The purpose of this study, I8F-MC-GPHJ (SURMOUNT-5), is to learn more about the effect of tirzepatide compared to semaglutide on the change in body weight in adults living with obesity or overweight (excess weight) who have weight-related medical problems. Semaglutide is an approved treatment used for long term weight management. Tirzepatide is being investigated for long term weight management. Study participants will be randomly assigned to receive either tirzepatide or semaglutide once weekly.
Approximately 700 participants globally will take part in the study including 40 in the UK. The study will last approximately 2 years.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/LO/0798
Date of REC Opinion
31 Jan 2023
REC opinion
Further Information Favourable Opinion