Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07891156, who can take part
Where in Canada
- Research Institute of the McGill University Health Centre Royal Victoria HospitalMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Trial code
- NCT07891156
- Record updated
- 23 October 2026
- Original description
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.Read full original descriptionShow less
Changes to Body Composition With Semaglutide vs. Placebo in Adults With Type 1 Diabetes and Overweight/Obesity: a Double-blinded, Randomized, Parallel Controlled 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.
Inclusion: 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: Prior hypersensitivity reaction to GLP1-RA (glucagon-like-peptide-1 receptor agonist); Any prior diagnostic history of eating disorder or suicidal attempts, or feelings of suicidal thoughts or behaviours in the last month**; 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*; 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; 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); HbA1c (glycated hemoglobin) ≥ 10% within the last 3 months; 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; Severe impairment of renal function with eGFR <30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months; Current use of non-insulin anti-hyperglycemic agents within the last month; 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); 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; Clinically significant gastroparesis, defined as persistent symptoms despite pharmacotherapy such as domperidone.