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New treatment option for Diabetes type1
Official title Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
ClinicalTrials.gov ID: NCT06411210
What this study is testing
What is Semaglutide Pen Injector?
Semaglutide Pen Injector is an investigational medicine, given as an once-weekly, being studied as a potential treatment for diabetes type1.
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
- 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.
- Phase 2: a mid-size study of how well it works
- 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 30
You may be able to join if
- 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...
- 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%)
You likely can't join if
- 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
See the full eligibility 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...
- Stated willingness to comply with all study procedures, medication regimen, and availability for the duration of the study
- Participants cannot be assigned by chance if any laboratory safety parameter at screening is outside the below extended laboratory ranges. For randomization, participants should have
- Creatinine \<1.0mg
- Triglycerides (\<400 mg/dl)
- ALT \<3.5 times the upper normal limit (UNL)
- 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...
- 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
- people 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
- people with severe hypoglycemia requiring hospitalization in the past 3 months
- Clinically significant gastroparesis
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 - 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 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.