NCT07891156 Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
| NCT ID | NCT07891156 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-10-13 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-10-13 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Melissa-Rosina Pasqua, MD, PhD
PRINCIPAL INVESTIGATOR
Research Institute of the McGill University Health Centre Royal Victoria Hospital
Frequently Asked Questions
Who can join the NCT07891156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07891156 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07891156 currently recruiting?
Yes, NCT07891156 is actively recruiting participants. Contact the research team at Jakob.Lenabat-persson@mail.mcgill.ca for enrollment information.
Where is the NCT07891156 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07891156 clinical trial?
NCT07891156 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Melissa-Rosina Pasqua, MD, PhD at Research Institute of the McGill University Health Centre Royal Victoria Hospital. The trial plans to enroll 40 participants.
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