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RECRUITING
NCT07891156
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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