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Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Summary
The goal of this 24 week double-blinded, randomized, parallel controlled clinical trial is to learn how semaglutide affects body composition in adults with type 1 diabetes and overweight/obesity. The main question to answer is: What effect does Semaglutide have on body composition in adults with type 1 diabetes and overweight/obesity compared to a placebo? Around 40 participants will: * Be randomly assigned to receive semaglutide or a placebo. * Self-administer the treatment drug once per week for 24 weeks. * Complete a series of tests, measurements and questionnaires throughout the study duration. * Attend a remote follow-up visit 4 weeks after the treatment is complete.
Official title: Changes to Body Composition With Semaglutide vs. Placebo in Adults With Type 1 Diabetes and Overweight/Obesity: a Double-blinded, Randomized, Parallel Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-10-13
Completion Date
2028-10-01
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Semaglutide
Semaglutide will be administered subcutaneously once a week for 24 weeks. The starting dose will be 0.25 mg, with increases every 4 weeks to 0.5 mg, 1.0 mg, 1.7 mg, and up to 2.4 mg. Dose can be de-escalated or not escalated based on participant symptoms, preference, or clinician judgement.
Placebo
A 0.9% normal saline placebo will be administered subcutaneously weekly for 24 weeks. The starting dose will be 0.25 mg, with increases every 4 weeks to 0.5 mg, 1.0 mg, 1.7 mg, and up to 2.4 mg.
Locations (1)
Research Institute of the McGill University Health Centre Royal Victoria Hospital
Montreal, Quebec, Canada