Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.

NCT07891156 | Recruiting Phase 2

• 1 other identifier: 2026-12414
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Randomized; Double-blinded; Parallel controlled; semaglutide

Outcome Measures

Primary Outcomes (1)

• Change in lean mass

  Change in total lean mass, measured in kilograms (kg).

  Baseline to 24 weeks of study drug use

Secondary Outcomes (24)

• Fat mass (kilograms)

  Baseline to 24 weeks

• Proportion of lean mass to fat mass (percentage)

  Baseline to 24 weeks

• Bone density (grams per cubic centimetre)

  Baseline to 24 weeks

• Appendicular lean mass and visceral fat mass (kilograms)

  Baseline to 24 weeks

• Weight (kilograms)

  Baseline to midpoint (weeks 15-16) and 24 weeks

Other Outcomes (9)

• Exercise sub-study: glucose levels

  Week 26-27 of study drug use

• Exercise sub-study: insulin needs

  week 26-27

• Number of episodes of severe hypoglycemia (safety outcome)

  Baseline to 24 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Semaglutide DRUG

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.

Semaglutide

Placebo DRUG

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.

Also known as: 0.9% normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Research Institute of the McGill University Health Centre Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Overweight; Obesity

Interventions

semaglutide; Saline Solution

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Melissa-Rosina Pasqua, MD, PhD

  Research Institute of the McGill University Health Centre Royal Victoria Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Lenabat

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: October 23, 2026
• Study Start: October 13, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-07

Locations

CA (1)