Type 1 Diabetes study: Semaglutide
Official title Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
ClinicalTrials.gov ID: NCT07891156
What this study is testing
What is Semaglutide?
This is an investigational once-weekly injectable medicine being studied to see if it changes body composition in adults with type 1 diabetes and overweight or obesity. It is designed to mimic a natural hormone in the body that helps regulate blood sugar and appetite.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether semaglutide changes body composition compared to a placebo in adults with type 1 diabetes and overweight/obesity.
- Who it's for
- Adults with type 1 diabetes who are overweight or obese.
- What's involved
- Participants will self‑inject the study drug once a week for 24 weeks, do tests, measurements and questionnaires during the study, and have a remote follow‑up visit 4 weeks after treatment ends.
- Time commitment
- The study lasts 24 weeks of weekly injections plus a remote visit 4 weeks later, with several tests and questionnaires during that time.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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).
You likely can't join 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.
- 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...
- Diabetic ketoacidosis (DKA) within the last 3 months (DKA refers to the need to present to medical attention and the requirement of intravenous...
See the full eligibility 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.
- Diabetic retinopathy assessment performed within the last 2 years, as per participant history.
- 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.
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.