RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 30 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks, 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After completing these baseline measures, participants will be randomized in a 2:1 ratio to receive weekly injected semaglutide (escalated to 2.4 mg or maximum tolerated dose) or placebo to treat obesity for 52 weeks."
  • "They will then complete a wean off of study drug (up to 4 weeks) and 2 weeks of additional monitoring for insulin titration."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how GLP-1 weight-loss medicine affects signs of heart and blood sugar health. It is for adults ages 18–30 with type 1 diabetes and obesity, or overweight with a weight-related health problem.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–30 years old and were diagnosed with type 1 diabetes at least 12 months ago.
  • Your BMI, a measure of weight compared with height, is at least 30, or at least 27 with a weight-related health problem.
  • Your HbA1c, a measure of average blood sugar, is 10% or less at screening and within the past 90 days.
  • In the past 90 days, your insulin dose has changed by no more than 15%, and your BMI by no more than 5%.
  • You use a real-time continuous glucose monitor to track blood sugar and plan to keep using it.
  • You can give written consent and agree to follow study visits, tests, and medicine instructions for the whole study.
  • If you could become pregnant or cause a pregnancy, you agree to use a highly effective birth control method starting at least 1 month before study group assignment, throughout the study, and for 2 months after the last dose. Complete avoidance of male-female sex also qualifies.
  • Your screening blood tests meet these limits: creatinine, a kidney test, below 1.0 mg; triglycerides, a blood fat, below 400 mg/dL; and ALT, a liver test, below 3.5 times the upper normal limit.

Who can't join

  • You used diabetes medicines besides insulin or weight-loss medicines in the past 6 months; use less than 0.5 units of insulin per kilogram of body weight per day; or take cholesterol-lowering medicines other than statins or omega-3 products.
  • You have had pancreatitis (swelling of the pancreas), kidney problems, or liver disease other than non-alcoholic fatty liver. You or a family member has had medullary thyroid cancer or Multiple Endocrine Neoplasia Type 2, a condition that can cause tumors in hormone-making glands.
  • You have a known or suspected allergy to semaglutide, its ingredients, or related products; a corn allergy; or serious gastroparesis, which slows stomach emptying.
  • You have a mental health condition that affects weight, including an eating disorder; a PHQ-9 depression score above 15; any past suicide attempt; or suicidal thoughts in the past 3 months.
  • You are pregnant, breastfeeding, planning to become pregnant, or not using adequate birth control.
  • You had diabetic ketoacidosis, a dangerous buildup of acids in the blood, in the past 6 months, or very low blood sugar that required a hospital stay in the past 3 months.
  • You cannot safely have an MRI scan or fear enclosed spaces enough to prevent the scan. You have anemia (low red blood cells), a blood condition that affects HbA1c results, or another health condition that prevents participation.
  • You were already assigned to a treatment group in this trial, or received another experimental drug or treatment in the past month. People who enrolled but were not assigned to a group may be screened again.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 (1)

CT