Obesity Complicating Type 1 Diabetes in Young Adults: Physiology and Impact of GLP-1 Analogue Anti-obesity Treatment on Cardiometabolic Risk Factors

Trial ID: NCT06411210

Interventional - Phase 2 - Recruiting

More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. GLP-1 analogues are anti-obesity medications that are cardioprotective in adults with type 2 diabetes, however evaluation of these agents in people with T1D has been limited to glycemic outcomes. Investigators aim to study the impact of GLP-1 analogue obesity treatment on markers of cardiometabolic risk in young adults with T1D and obesity.

Conditions

• Diabetes type1
• Obesity

Interventions

• Semaglutide Pen Injector
• Placebo

Eligibility

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

Sponsor

Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Novo Nordisk A/S

Source: ClinicalTrials.gov

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