Type 1 DiabetesPhase 2/3SEMA-T1D-BODYNCT07891156
Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
A Phase 2/3 study testing Semaglutide in people with Type 1 Diabetes and Overweight , Obesity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Overweight , Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2026to 1 Oct 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Research Institute of the McGill University Health Centre Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Jakob Lenabat, 438 822 3302, Jakob.Lenabat-persson@mail.mcgill.ca; mcgill.pasqua.lab@gmail.com
Melissa-Rosina Pasqua, MD, PhD
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes, Overweight , Obesity
- Being tested
- Semaglutide, Placebo
- Keywords
- Randomized, Double-blinded, Parallel controlled, semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 1, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
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.
PlaceboDrug
Also called 0.9% normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean mass
Change in total lean mass, measured in kilograms (kg).
Measured: Baseline to 24 weeks of study drug use
Secondary outcomes (24)
Fat mass (kilograms)
Change in total fat mass measured in kilograms (kg) using dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline to 24 weeks
Proportion of lean mass to fat mass (percentage)
Change in the proportion of lean mass relative to fat mass as a percentage (%), measured using dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline to 24 weeks
Bone density (grams per cubic centimetre)
Change in bone density measured in grams per cubic centimetre (g/cm³) using dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline to 24 weeks
Appendicular lean mass and visceral fat mass (kilograms)
Change in appendicular lean mass and visceral fat mass measured in kilograms (kg) using dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline to 24 weeks
Weight (kilograms)
Change in body weight, measured in kilograms (kg), on an electronic scale.
Measured: Baseline to midpoint (weeks 15-16) and 24 weeks
Hip circumference (centimetres)
Change in hip circumference, measured in centimetres (cm). Use a measuring tape to measure the largest circumference around the buttock area.
Measured: Baseline to midpoint (weeks 15-16) and 24 weeks
Waist circumference (centimetres)
Change in waist circumference, measured in centimetres (cm) using anthropometric measurements. Use a measuring tape to measure at the level of the ischial crests as a landmark.
Measured: Baseline to midpoint (weeks 15-16) and 24 weeks
Blood pressure (millimeters of mercury)
Change in blood pressure, measured in millimetres of mercury (mmHg), after a 5-minute reset, measured 3 times. We will average the 3 values.
Measured: Baseline to 24 weeks
Mean peak torque
Change in mean peak torque during isokinetic and isometric knee extension/flexion, measured via Biodex. Results will be recorded as weight-based torque (Nm/kg).
Measured: Baseline to 24 weeks
Handgrip strength test
Change in maximum handgrip strength for the dominant and non-dominant hands, measured in kilograms (kg) using a hand dynamometer.
Measured: Baseline to 24 weeks
Six-minute walk test (distance in metre)
Change in the distance walked during the six-minute walk test (6MWT), measured in metres (m).
Measured: Baseline to 24 weeks
General physical activity (steps/day)
Change in average number of steps per day measured using an accelerometer.
Measured: Baseline to midpoint (weeks 15-16) and 24 weeks
Time spent in different intensities of physical activity
Change in time spent in light, moderate, and vigorous physical activity, measured in minutes per day using an accelerometer.
Measured: Baseline to midpoint (weeks 15-16) and 24 weeks
Mean total energy consumed per day
Change in mean total energy consumed per day, measured in kilocalories (kcals), using Keenoa.
Keenoa - Food diary smartphone application
Measured: Baseline to midpoint to 24 weeks
Mean total carbohydrates/fat/protein
Change in mean daily intake of carbohydrates, fat, and protein, measured in grams per day (g/day) and as a proportion of energy, using Keenoa.
Keenoa - Food diary smartphone application
Measured: Baseline to midpoint (weeks 15-16) and 24 weeks
Three-factor eating questionnaire R-18 scores
Change in the Three-Factor Eating Questionnaire (TFEQ-R18) is an 18-item validated questionnaire regarding eating behaviour and restraint, including subscores of uncontrolled eating, cognitive restraint, and emotional eating.
Measured: Baseline to 24 weeks
Canadian Food Intake Screener score
Change in the Canadian Food Intake Screener score (CFIS): a 16-item survey assessing healthy eating habits in relation to the Canadian Food Guide
Measured: Baseline to 24 weeks
Modified Hypoglycemia Fear Survey II (mHFS-II).
A survey validated in type 1 diabetes to quantify fear of hypoglycemia based on a 5-point Likert scale, with higher scores associated with worsened fear of hypoglycemia. There are 2 subscales: i) HFS-Fear and ii) HFS-Behaviour.
This has a total of 32 items.
Measured: Baseline to 24 weeks
Diabetes Distress Scale (DDS).
A 17-item survey to quantify diabetes distress based on a 6-point Likert scale, with higher points associated with worsened diabetes distress. A mean item score of 2.0-2.9 signifies moderate distress, whereas a mean item score ≥ 3.0 signifies high distress.
Measured: Baseline to 24 weeks
Diabetes Quality-of-Life Brief Clinical Inventory (DQOLBCI).
A 15-item survey validated in type 1 diabetes to assess quality of life reflective of treatment satisfaction. It is based on a 5-point Likert scale, with lower scores reflective of better
Measured: Baseline to 24 weeks
Change in individual Continuous Glucose Monitoring metrics
- Time spent between 3.9-10 millimoles per litre (Time in Range) as %
- Time spent < 3.9 millimoles per litre (mmol/L) (Time below Range) as %
- Time spent above 10 millimoles per litre (mmol/L) (Time above range) as %
Measured: Baseline to midpoint (weeks 15-16) and 24 weeks
Glycated hemoglobin
Measure of average glucose control over the last 3-4 months (in keeping with the lifespan of red blood cells), with a target of < 7 percent. Measured as %.
Measured: Baseline to midpoint (15-16 weeks) and 24 weeks
Mean daily insulin requirements
Mean daily insulin requirements, including total, basal and bolus.
Measured: Baseline to midpoint (15-16 weeks) and 24 weeks
Lipid levels
Total cholesterol, Low-Density Lipoprotein-cholesterol, High-Density Lipoprotein-cholesterol, triglycerides (mmol/L)
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start13 Oct 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa-Rosina Pasqua, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Melissa-Rosina Pasqua, MD, PhD, Principal investigator, Research Institute of the McGill University Health Centre Royal Victoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891156
- Sponsor's protocol ID
- 2026-12414
- Acronym
- SEMA-T1D-BODY
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing would be case-by-case basis to protect the anonymity of participants and to ensure it is for non-commercial use.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes to Body Composition With Semaglutide vs. Placebo in Adults With Type 1 Diabetes and Overweight/Obesity: a Double-blinded, Randomized, Parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT07891156
- Acronym / sponsor ID
- SEMA-T1D-BODY / 2026-12414
- Conditions
- Type 1 Diabetes, Overweight , Obesity
- Keywords
- Randomized, Double-blinded, Parallel controlled, semaglutide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideParticipants 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 | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide 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. | Drug | Semaglutide |
| PlaceboAlso: 0.9% normal salineA 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. | Drug | Placebo |
Primary outcome
Change in lean mass
Time frame: Baseline to 24 weeks of study drug use
Change in total lean mass, measured in kilograms (kg).
24 secondary outcomes
Fat mass (kilograms)
Time frame: Baseline to 24 weeks
Proportion of lean mass to fat mass (percentage)
Time frame: Baseline to 24 weeks
Bone density (grams per cubic centimetre)
Time frame: Baseline to 24 weeks
Appendicular lean mass and visceral fat mass (kilograms)
Time frame: Baseline to 24 weeks
Weight (kilograms)
Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks
Hip circumference (centimetres)
Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks
Waist circumference (centimetres)
Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks
Blood pressure (millimeters of mercury)
Time frame: Baseline to 24 weeks
Mean peak torque
Time frame: Baseline to 24 weeks
Handgrip strength test
Time frame: Baseline to 24 weeks
Six-minute walk test (distance in metre)
Time frame: Baseline to 24 weeks
General physical activity (steps/day)
Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks
Time spent in different intensities of physical activity
Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks
Mean total energy consumed per day
Time frame: Baseline to midpoint to 24 weeks
Mean total carbohydrates/fat/protein
Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks
Three-factor eating questionnaire R-18 scores
Time frame: Baseline to 24 weeks
Canadian Food Intake Screener score
Time frame: Baseline to 24 weeks
Modified Hypoglycemia Fear Survey II (mHFS-II).
Time frame: Baseline to 24 weeks
Diabetes Distress Scale (DDS).
Time frame: Baseline to 24 weeks
Diabetes Quality-of-Life Brief Clinical Inventory (DQOLBCI).
Time frame: Baseline to 24 weeks
Change in individual Continuous Glucose Monitoring metrics
Time frame: Baseline to midpoint (weeks 15-16) and 24 weeks
Glycated hemoglobin
Time frame: Baseline to midpoint (15-16 weeks) and 24 weeks
Mean daily insulin requirements
Time frame: Baseline to midpoint (15-16 weeks) and 24 weeks
Lipid levels
Time frame: Baseline to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided. Sharing would be case-by-case basis to protect the anonymity of participants and to ensure it is for non-commercial use.
Related trials for Type 1 Diabetes
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa-Rosina Pasqua, MD, PhD principal investigator
Research Institute of the McGill University Health Centre Royal Victoria Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Semaglutide in people with Type 1 Diabetes and Overweight , Obesity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Lenabat (438 822 3302, Jakob.Lenabat-persson@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean mass (time frame: Baseline to 24 weeks of study drug use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.