GLP-1 Peptide Atlas, by Delfa

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

Lead sponsor

Yale University

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

•BMI ≥30•HbA1c ≤10%

Primary endpoints

•VAT/(VAT+SAT)•Hepatic insulin resistance•Triglycerides, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06411210

Org study ID2000035452

Secondary ID1R01DK134398-01A1

Timeline

Milestones

Study first posted2024-05-13actual

Study start2024-07-16actual

Last update posted2025-05-02actual

Primary completion2028-04-30estimated

Study completion2028-06-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age30 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

4 endpoints

Primary/protocol endpoint

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

Time frame:baseline and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in weight from baseline to 12 months

Time frame:baseline and 12 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in percent body fat from baseline to 12 months

Time frame:baseline and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI from baseline to 12 months

Time frame:baseline and 12 months

BMI, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change in hepatic insulin resistance from baseline to 12 months

Time frame:baseline and 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in mean glucose concentration

Time frame:baseline and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Mean time in normal glucose range

Time frame:baseline and 12 months

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Mean time in level 1 and 2 hyperglycemia, high range

Time frame:baseline and 12 months

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Mean time in level 1 and 2 hyperglycemia, low range

Time frame:baseline and 12 months

CGM time-above-range

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Change in triglycerides from baseline to 12 months

Time frame:baseline and 12 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.