GLP-1 analogue treatment for obesity in young adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of the GLP-1 analogue semaglutide on cardiometabolic risk factors in young adults aged 18-30 with type 1 diabetes and obesity. Participants will receive either semaglutide or a placebo for 12 months, with assessments including abdominal MRI, glucose metabolism tests, and body composition analysis. The study aims to fill knowledge gaps regarding the potential benefits of anti-obesity treatment in this high-risk population. The trial is designed as a single-center, double-blinded, placebo-controlled study to ensure robust results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-30 years with T1D whose BMI meets FDA approval criteria for anti-obesity pharmacotherapy (BMI ≥30 kg/m2 alone or BMI ≥27 kg/m2 with a weight-related comorbidity)
* Clinical diagnosis of T1D
* Diabetes duration diagnosed ≥ 12 months ago
* HbA1c ≤10% at screening and within the past 90 days
* Stable reported insulin dosing in the past 90 days (within 15%)
* Stable reported BMI in the past 90 days (within 5%)
* Ability to provide written informed consent before any trial-related activities
* Use of real-time continuous glucose monitoring and planned continued use
* Females and males of childbearing potential willing to use highly effective methods of contraception for at least 1 month prior to randomization and agreement to use such a method during study participation and for 2 months after the last dose of study medication administration: Combined estrogen-progestogen contraception including: oral, intravaginal, transdermal (patch), Progestogen-only contraception: oral, injectable or implantable, Placement of an intrauterine device or intrauterine system, Bilateral tubal occlusion (fallopian tubes are blocked), Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate), or Complete sexual abstinence from male-female sex)
* Stated willingness to comply with all study procedures, medication regimen, and availability for the duration of the study
* Participants cannot be randomized if any laboratory safety parameter at screening is outside the below extended laboratory ranges. For randomization, participants should have

  1. Creatinine \<1.0mg
  2. Triglycerides (\<400 mg/dl)
  3. ALT \<3.5 times the upper normal limit (UNL)

Exclusion Criteria:

* Use of adjunctive diabetes therapies or anti-obesity medications (including any GLP-1 agonist) currently or within the past 6 months.
* Insulin dosing \<0.5 units/kg/day
* Current psychiatric conditions impacting weight, including known eating disorders
* Contraindications to study medications, including:

  * Personal history of pancreatitis, renal impairment, or known liver disease other than non-alcoholic hepatic steatosis
  * Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia Type 2
  * Known or suspected allergy to semaglutide, excipients, or related products.
* Use of lipid lowering medications other than statins and omega-3 products
* Previous randomization in this trial. Participants who enrolled but did not randomize can be re-screened. Potential reasons for enrolment without randomization include scheduling conflicts for the baseline studies, or for females, not yet meeting the highly effective methods of contraception criteria.
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
* Diabetic ketoacidosis in the past 6 months
* Not meeting MRI safety criteria or claustrophobia preventing participation in the MRI
* Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation.
* Treatment with another investigational drug or other intervention within the past 1 month
* Subjects with a PHQ-9 score \>15 or those found to have a lifetime history of suicide attempts, or suicidal ideation within the past 3 months on the C-SSRS
* Corn allergy
* Subjects with severe hypoglycemia requiring hospitalization in the past 3 months
* Clinically significant gastroparesis

Where it's running

• Yale Pediatric Diabetes Center, Adult and Children's Progam
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Michelle Van Name, MD — Yale University
• Study coordinator: Rehema Mtawali
• Email: rehema.mtawali@yale.edu
• Phone: 475-414-4035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.