Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 24-week, double-blind, randomized, parallel-controlled trial enrolling adults with type 1 diabetes and overweight/obesity. Participants are randomly assigned to receive semaglutide or placebo and self-administer the study drug weekly. The study will monitor body composition and other health measures through a series of tests and questionnaires, with a remote follow-up visit 4 weeks after treatment ends. The goal is to determine how semaglutide affects body composition compared with placebo in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-65 years old
* Clinical diagnosis of T1D (type 1 diabetes) for ≥ 1 year, as per clinician judgement.
* BMI (Body mass index) ≥ 27 kg/m2
* Use of multi-daily injections or insulin pump therapy.
* 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. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause or have a disclosed medical condition causing sterility (e.g. hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.
* Diabetic retinopathy assessment performed within the last 2 years, as per participant history.

Exclusion Criteria:

* Pre-existing conditions limiting physical activity, specifically inability to walk for 6 minutes.
* Active proliferative diabetic retinopathy requiring surgery or laser/injectable therapy within the last 3 months.

\*If a history of proliferative retinopathy is present within the last year, written permission from the eligible participant's ophthalmologist or optometrist is required\*

* HbA1c (glycated hemoglobin) ≥ 10% within the last 3 months.
* Current use of non-insulin anti-hyperglycemic agents within the last month.
* Severe hypoglycemic episode within the last 3 months, defined as an event where glycemia was \< 4 mmol/L, resulting in seizure, loss of consciousness, or need for third-party assistance in treatment.
* Diabetic ketoacidosis (DKA) within the last 3 months (DKA refers to the need to present to medical attention and the requirement of intravenous insulin due to ketones)
* History of bariatric surgery
* Personal history of acute/chronic pancreatitis or gallstone disease without cholecystectomy.
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
* Severe impairment of renal function with eGFR \<30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months.
* Use of supraphysiological doses of glucocorticoids in the last 3 months, and/or expected use at some point in the next 6 months.
* Planned or ongoing pregnancy
* Breastfeeding individuals
* Prior hypersensitivity reaction to GLP1-RA (glucagon-like-peptide-1 receptor agonist)
* Clinically significant gastroparesis, defined as persistent symptoms despite pharmacotherapy such as domperidone.
* Any prior diagnostic history of eating disorder or suicidal attempts, or feelings of suicidal thoughts or behaviours in the last month\*\*
* Unstable angina, or myocardial infarction/ cardiovascular surgery / coronary stenting in the last month.
* Any serious medical or psychiatric illness likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia).

Where it's running

• Research Institute of the McGill University Health Centre Royal Victoria Hospital
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Melissa-Rosina Pasqua, MD, PhD — Research Institute of the McGill University Health Centre Royal Victoria Hospital
• Study coordinator: Jakob Lenabat
• Email: Jakob.Lenabat-persson@mail.mcgill.ca
• Phone: 438 822 3302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.