SEMA-T1D-BODY

RecruitingPhase 2, PHASE3

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

Changes to Body Composition With Semaglutide vs. Placebo in Adults With Type 1 Diabetes and Overweight/Obesity: a Double-blinded, Randomized, Parallel Controlled Trial

Lead sponsor

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Type 1 diabetes

Eligibility highlights

•BMI ≥27

Primary endpoint

•Lean mass

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07891156

Org study ID2026-12414

Timeline

Milestones

Study start2026-10-13estimated

Study first posted2026-10-23actual

Last update posted2026-10-23actual

Primary completion2028-09-01estimated

Study completion2028-10-01estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot 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).

Endpoints (34)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Renal / kidney

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

6 endpoints

Primary/protocol endpoint

Change in lean mass

Time frame:Baseline to 24 weeks of study drug use

change from baseline, improvement

Secondary/protocol endpoint

Fat mass (kilograms)

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint

Proportion of lean mass to fat mass (percentage)

Time frame:Baseline to 24 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Appendicular lean mass and visceral fat mass (kilograms)

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint

Weight (kilograms)

Time frame:Baseline to midpoint (weeks 15-16) and 24 weeks

descriptive

Secondary/protocol endpoint

Waist circumference (centimetres)

Time frame:Baseline to midpoint (weeks 15-16) and 24 weeks

descriptive

Glycemic / diabetes

8 endpoints

Secondary/protocol endpoint

Diabetes Distress Scale (DDS).

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint

Diabetes Quality-of-Life Brief Clinical Inventory (DQOLBCI).

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint

Change in individual Continuous Glucose Monitoring metrics

Time frame:Baseline to midpoint (weeks 15-16) and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Glycated hemoglobin

Time frame:Baseline to midpoint (15-16 weeks) and 24 weeks

descriptive

Secondary/protocol endpoint

Mean daily insulin requirements

Time frame:Baseline to midpoint (15-16 weeks) and 24 weeks

descriptive

Other/protocol endpoint

Exercise sub-study: glucose levels

Time frame:Week 26-27 of study drug use

descriptive

Other/protocol endpoint

Exercise sub-study: insulin needs

Time frame:week 26-27

descriptive

Other/protocol endpoint

Diabetic retinopathy (safety outcome)

Time frame:Baseline to 24 weeks

descriptive

Renal / kidney

2 endpoints

Other/protocol endpoint

Serum creatinine (safety outcome)

Time frame:Baseline to midway to 24 weeks

descriptive

Other/protocol endpoint

Urine albumin: creatinine ratio (safety outcome

Time frame:Baseline to midway to 24 weeks

ratio, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Blood pressure (millimeters of mercury)

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint

Lipid levels

Time frame:Baseline to 24 weeks

descriptive

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Three-factor eating questionnaire R-18 scores

Time frame:Baseline to 24 weeks

descriptive

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Modified Hypoglycemia Fear Survey II (mHFS-II).

Time frame:Baseline to 24 weeks

descriptive

Other/protocol endpoint

Number of episodes of severe hypoglycemia (safety outcome)

Time frame:Baseline to 24 weeks

event count, event

Other/protocol endpoint

Number of episodes of ketone levels ≥ 1.5 millimoles per liter (safety outcome)

Time frame:Baseline to 24 weeks

threshold achievement, event

Other/protocol endpoint

Gastrointestinal side effects (safety outcome)

Time frame:Baseline to 24 weeks

descriptive

Other (unclassified)

11 endpoints

Secondary/protocol endpoint/low confidence

Bone density (grams per cubic centimetre)

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Hip circumference (centimetres)

Time frame:Baseline to midpoint (weeks 15-16) and 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Mean peak torque

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Handgrip strength test

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Six-minute walk test (distance in metre)

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

General physical activity (steps/day)

Time frame:Baseline to midpoint (weeks 15-16) and 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Time spent in different intensities of physical activity

Time frame:Baseline to midpoint (weeks 15-16) and 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Mean total energy consumed per day

Time frame:Baseline to midpoint to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Mean total carbohydrates/fat/protein

Time frame:Baseline to midpoint (weeks 15-16) and 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Canadian Food Intake Screener score

Time frame:Baseline to 24 weeks

descriptive

Other/protocol endpoint/low confidence

Liver enzymes

Time frame:Baseline to midway to 24 week

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.