Recruiting
Phase 2
Phase 3

Semaglutide

Sponsor:

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

Code:

NCT07891156

Conditions

Type 1 Diabetes

Overweight , Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Placebo

Study Details

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.

Conditions

Type 1 Diabetes

Overweight , Obesity

Study ID

NCT07891156

Start date

Oct 13, 2026

Status verified date

Jul, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide

Participants will receive semaglutide via subcutaneous injection once a week for 24 weeks. Dosing will begin at 0.25 mg and will be increased every 4 weeks, to a maximum of 2.4 mg, if tolerated.

placebo comparator: Placebo

Participants will receive a 0.9% normal saline placebo via subcutaneous injection once a week for 24 weeks. Dosing will begin at 0.25 mg and increase every 4 weeks until a maximum of 2.4 mg.

Interventions

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.

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.

Primary outcome measure

  • Change in lean mass [ Time Frame: Baseline to 24 weeks of study drug use ]

Central Contacts and Locations

Central contacts

Jakob Lenabat

438 822 3302Jakob.Lenabat-persson@mail.mcgill.ca

Locations

Research Institute of the McGill University Health Centre Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Jakob Lenabat

438 822 3302Jakob.Lenabat-persson@mail.mcgill.ca; mcgill.pasqua.lab@gmail.com

Principal Investigator:

Melissa-Rosina Pasqua, MD, PhD

More Information

Sponsor

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

Last update posted

Oct 23, 2026

Last verified

Jul, 2026

Keywords

  • Randomized
  • Double-blinded
  • Parallel controlled
  • semaglutide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.