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Diabetes type1Phase 2NCT06411210

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

A Phase 2 study testing Semaglutide Pen Injector in people with Diabetes type1 and Obesity, run by Yale University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Diabetes type1, Obesity
What is being tested?
Semaglutide Pen Injector
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteUnited States
Study dates
16 Jul 2024to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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%)
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  • 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
  • Creatinine <1.0mg
  • Triglycerides (<400 mg/dl)
  • ALT <3.5 times the upper normal limit (UNL)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rehema Mtawali contact

475-414-4035

rehema.mtawali@yale.edu

United States1 site, 1 recruiting

  • Yale Pediatric Diabetes Center, Adult and Children's Progam

    New Haven, Connecticut, 06520

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

This proposal will address critical knowledge gaps of understanding potential salutary effects of GLP-1 analogue anti-obesity treatment with weekly semaglutide 2.4 mg on cardiometabolic risk factors in young adults with T1D and obesity, the group of people with T1D at greatest risk for future cardiovascular disease. Investigators aim to examine the impact of 12 months of treatment with weekly semaglutide 2.4 mg compared to placebo on abdominal adipose tissue distribution, glucose metabolism and postprandial atherosclerotic lipoproteins in young people with T1D and obesity.

This is a single-center, parallel group, double-blinded, placebo controlled, randomized clinical trial. After informed consent procedures, participants will complete four assessments: 1) Abdominal MRI to evaluate abdominal adipose partitioning, 2) Euglycemic hyperinsulinemic clamp with isotope tracer enhancement to evaluate gluconeogenesis and glucose, glycerol, and b-hydroxybutyrate turnover to assess measures of insulin resistance, 3) DEXA scan to evaluate total body composition, and 4) a High-fat mixed meal tolerance test to evaluate postprandial lipemia. 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. At 52 weeks, participants will repeat the baseline tests. They will then complete a wean off of study drug (up to 4 weeks) and 2 weeks of additional monitoring for insulin titration.

Being tested
Semaglutide Pen Injector, Placebo
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide Pen InjectorDrug

    Escalated to 2.4mg or max tolerated dose

  • PlaceboDrug

    Matched placebo.

Study groups in NCT06411210
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants in this arm will receive semaglutide (escalated to 2.4mg or max tolerated dose) weekly for 12 months. Then a 4 week wean period plus 2 weeks as needed insulin titration.
Receives: Drug: Semaglutide Pen Injector
PlaceboPlacebo comparatorParticipants in this arm will receive a matched placebo weekly for 12 months. Then a 4 week wean period plus 2 weeks as needed insulin titration.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in VAT/(VAT+SAT) from baseline to 12 months

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

    Measured: baseline and 12 months

  2. Change in hepatic insulin resistance from baseline to 12 months

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

    Measured: baseline and 12 months

  3. Change in triglycerides from baseline to 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.

    Measured: baseline and 12 months

Secondary outcomes (7)

  1. Change in weight from baseline to 12 months

    Mean change in weight (kilograms) assessed using a scale

    Measured: baseline and 12 months

  2. Change in percent body fat from baseline to 12 months

    Mean change in percent body fat assessed using DEXA scan measurements

    Measured: baseline and 12 months

  3. Change in BMI from baseline to 12 months

    Mean change in BMI calculated using measured height and weight.

    Measured: baseline and 12 months

  4. Change in mean glucose concentration

    Change in mean glucose concentration. Data collected as available using participant's personal clinical continuous glucose monitor.

    Measured: baseline and 12 months

  5. Mean time in normal glucose range

    Mean time in normal glucose range. Range=70-180 mg/dl and 3.9-10 mmol/L. Data collected as available using participant's personal clinical continuous glucose monitor.

    Measured: baseline and 12 months

  6. Mean time in level 1 and 2 hyperglycemia, high range

    Mean time in level 1 and 2 hyperglycemia. Range= >180, >250 mg/dL and >10, >13.9 mmol/L. Data collected as available using participant's personal clinical continuous glucose monitor.

    Measured: baseline and 12 months

  7. Mean time in level 1 and 2 hyperglycemia, low range

    Mean time in level 1 and 2 hyperglycemia. Range= <70, <54 mg/dL and <3.9, <3.0 mmol/L. Data collected as available using participant's personal clinical continuous glucose monitor.

    Measured: baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2024
  2. Study start16 Jul 2024
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06411210
Sponsor's protocol ID
2000035452
Other IDs
1R01DK134398-01A1
Status last verified
Jul 2026
First submitted
7 May 2024
Last updated
4 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide Pen Injector in people with Diabetes type1 and Obesity, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rehema Mtawali (475-414-4035, rehema.mtawali@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VAT/(VAT+SAT) from baseline to 12 months (time frame: baseline and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06411210.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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