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GLP-1 Analogue Anti-obesity Treatment for Type 1 Diabetes

This study is looking at how a medication called semaglutide (a GLP-1 analogue) affects young adults (ages 18-30) who have both type 1 diabetes and obesity. Semaglutide is already used to treat obesity. Researchers want to see if it can also improve markers of heart and blood vessel health in people with type 1 diabetes. You might be able to join if you have type 1 diabetes, are between 18 and 30 years old, and meet certain body mass index (BMI) criteria. The study will measure changes in fat distribution around your organs (VAT), how your body uses insulin in the liver, and triglyceride (a type of fat in the blood) levels over 12 months to see if the treatment is successful. The current recruitment status is unclear.

Study design
This is a randomized, double-blinded, placebo-controlled study involving 54 participants. Participants will receive either semaglutide or a matched placebo.
What's involved
You would undergo four assessments at the start, including an abdominal MRI, a test to measure insulin resistance, a DEXA scan for body composition, and a high-fat meal tolerance test. After these initial tests, you would receive weekly injections for 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting treatment to measure changes in the study's main outcomes.

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NCT06411210

Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment

Recruiting
PHASE2Ages 18–30InterventionalBasic science
Yale University
~54 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Semaglutide Pen InjectorPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in VAT/(VAT+SAT) from baseline to 12 months
Measured over baseline and 12 months
+2 more outcomes measured

Conditions

Diabetes type1
Obesity

Explore related trials

ObesityType 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Michelle Van Name, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Rehema Mtawali
[email protected]
475-414-4035
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in VAT/(VAT+SAT) from baseline to 12 monthsbaseline and 12 months

    Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year.

  • Change in hepatic insulin resistance from baseline to 12 monthsbaseline and 12 months

    Hepatic insulin resistance, measured by serum concentration of beta-hydroxybutyrate (surrogate marker of acetyl-CoA, which regulates gluconeogenesis), changes over 1 year.

  • Change in triglycerides from baseline to 12 monthsbaseline and 12 months

    Change in triglycerides after a high-fat mixed meal tolerance test, expressed as the total Area Under the Curve (AUCTG) over 6 hours from baseline to 1 year.