{ "data": { "asOf": "2026-10-30T22:26:30.802Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07891156", "title": "Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.", "scientificTitle": "Changes to Body Composition With Semaglutide vs. Placebo in Adults With Type 1 Diabetes and Overweight/Obesity: a Double-blinded, Randomized, Parallel Controlled Trial", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE2", "PHASE3" ], "conditions": [ "Type 1 Diabetes", "Overweight , Obesity" ], "interventions": [ { "name": "Semaglutide", "type": "DRUG", "description": "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." }, { "name": "Placebo", "type": "DRUG", "description": "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." } ], "sponsor": { "name": "McGill University Health Centre/Research Institute of the McGill University Health Centre", "type": "OTHER" }, "locations": [ { "city": "Montreal", "country": "Canada", "facility": "Research Institute of the McGill University Health Centre Royal Victoria Hospital" } ], "outcomes": { "other": [ "Exercise sub-study: glucose levels", "Exercise sub-study: insulin needs", "Number of episodes of severe hypoglycemia (safety outcome)", "Number of episodes of ketone levels ≥ 1.5 millimoles per liter (safety outcome)", "Gastrointestinal side effects (safety outcome)", "Diabetic retinopathy (safety outcome)", "Serum creatinine (safety outcome)", "Urine albumin: creatinine ratio (safety outcome", "Liver enzymes" ], "primary": [ "Change in lean mass" ], "secondary": [ "Fat mass (kilograms)", "Proportion of lean mass to fat mass (percentage)", "Bone density (grams per cubic centimetre)", "Appendicular lean mass and visceral fat mass (kilograms)", "Weight (kilograms)", "Hip circumference (centimetres)", "Waist circumference (centimetres)", "Blood pressure (millimeters of mercury)", "Mean peak torque", "Handgrip strength test", "Six-minute walk test (distance in metre)", "General physical activity (steps/day)", "Time spent in different intensities of physical activity", "Mean total energy consumed per day", "Mean total carbohydrates/fat/protein", "Three-factor eating questionnaire R-18 scores", "Canadian Food Intake Screener score", "Modified Hypoglycemia Fear Survey II (mHFS-II).", "Diabetes Distress Scale (DDS).", "Diabetes Quality-of-Life Brief Clinical Inventory (DQOLBCI).", "Change in individual Continuous Glucose Monitoring metrics", "Glycated hemoglobin", "Mean daily insulin requirements", "Lipid levels" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Age 18-65 years old\n* Clinical diagnosis of T1D (type 1 diabetes) for ≥ 1 year, as per clinician judgement.\n* BMI (Body mass index) ≥ 27 kg/m2\n* Use of multi-daily injections or insulin pump therapy.\n* Use of CGM (continuous glucose monitoring).\n* 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.\n* Diabetic retinopathy assessment performed within the last 2 years, as per participant history.\n\nExclusion Criteria:\n\n* Pre-existing conditions limiting physical activity, specifically inability to walk for 6 minutes.\n* Active proliferative diabetic retinopathy requiring surgery or laser/injectable therapy within the last 3 months.\n\n\\*If a history of proliferative retinopathy is present within the last year, written permission from the eligible participant's ophthalmologist or optometrist is required\\*\n\n* HbA1c (glycated hemoglobin) ≥ 10% within the last 3 months.\n* Current use of non-insulin anti-hyperglycemic agents within the last month.\n* 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.\n* 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)\n* History of bariatric surgery\n* Personal history of acute/chronic pancreatitis or gallstone disease without cholecystectomy.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe impairment of renal function with eGFR \\<30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months.\n* Use of supraphysiological doses of glucocorticoids in the last 3 months, and/or expected use at some point in the next 6 months.\n* Planned or ongoing pregnancy\n* Breastfeeding individuals\n* Prior hypersensitivity reaction to GLP1-RA (glucagon-like-peptide-1 receptor agonist)\n* Clinically significant gastroparesis, defined as persistent symptoms despite pharmacotherapy such as domperidone.\n* Any prior diagnostic history of eating disorder or suicidal attempts, or feelings of suicidal thoughts or behaviours in the last month\\*\\*\n* Unstable angina, or myocardial infarction/ cardiovascular surgery / coronary stenting in the last month.\n* 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).", "maximumAge": "65 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 40 }, "startDate": "2026-10-13", "completionDate": "2028-10-01", "lastUpdated": "2026-10-23T00:00:00.000Z", "firstPosted": "2026-10-23T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07891156" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07891156", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07891156", "sourceUrl": "https://clinicaltrials.gov/study/NCT07891156", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:39.326Z", "payloadSha256": "e8caa56261fd5dad41d26abd309cee7394a0c65e7cd0d932d03a9f52001dfffc", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07891156", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07891156", "verifyAt": "https://clinicaltrials.gov/study/NCT07891156", "retrievedAt": "2026-10-28T04:32:39.326Z", "payloadSha256": "e8caa56261fd5dad41d26abd309cee7394a0c65e7cd0d932d03a9f52001dfffc", "text": "ClinicalTrials.gov, record NCT07891156 (https://clinicaltrials.gov/study/NCT07891156), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07891156, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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