40 Participants NeededMy employer runs this trial

Semaglutide for Type 1 Diabetes

(SEMA-T1D-BODY Trial)

JL
Overseen ByJakob Lenabat
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MP

Melissa-Rosina Pasqua, MD, PhD

Principal Investigator

Research Institute of the McGill University Health Centre Royal Victoria Hospital

Are You a Good Fit for This Trial?

This trial is for adults with type 1 diabetes who are also overweight or obese. Participants must be able to self-administer medication and take part in study visits and tests.

Inclusion Criteria

BMI (Body mass index) ≥ 27 kg/m2
Use of CGM (continuous glucose monitoring)
Agreement to the use of a highly effective method of birth control in persons of child-bearing age if sexually active and active avoidance of pregnancy during the trial
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Exclusion Criteria

Prior hypersensitivity reaction to GLP1-RA
Any prior diagnostic history of eating disorder or suicidal attempts or suicidal thoughts or behaviours in the last month
Any serious medical or psychiatric illness likely to interfere with study participation as per investigator judgment (e.g. cirrhosis, active cancer, decompensated schizophrenia)
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What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide

Trial Overview

The study compares semaglutide (a weekly injection) to a placebo over 24 weeks, aiming to see how semaglutide affects body composition in people with type 1 diabetes and excess weight. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+