What this trial means for you
This study is recruiting now at 1 US site. It's studying Semaglutide Pen Injector, Placebo for diabetes type1, obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Connecticut
- Yale Pediatric Diabetes Center, Adult and Children's Progam — New Haven · Recruiting now
View the official record on ClinicalTrials.gov →
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