GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 2

Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease

Semaglutide, 2.4mg, Once Weekly: Effects on Beta-cell Preservation and Reduction of Intrahepatic Triglyceride Content in Obese Youth With Prediabetes (IGT)/Early Type 2 Diabetes (T2D) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Lead sponsor

Yale University

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Key I/E criteria

•BMI ≥85•HbA1c 5.7-6.5%

Primary endpoints

•Oral Disposition Index (oDI)•MRI-PDFF, % 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 IDNCT05067621

Org study ID2000031181

Secondary ID2R01DK111038-06A1

Timeline

Milestones

Study first posted2021-10-05actual

Study start2023-07-17actual

Last update posted2026-04-15actual

Primary completion2026-12estimated (month precision)

Study completion2027-01estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age21 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects diagnosed with Pre-impaired glucose tolerance (pre-IGT) (2h glucose ≥ 130 mg/dl to ≤ 200 mg/dl post-OGTT) OR impaired glucose tolerance (2h glucose ≥140 to <200 mg/dl post-OGTT OR HbA1c ≥5.7% to <6.5%), OR new-onset T2D (≤24 months duration, 2h glucose >200 and HbA1c >6.5% to10%) treated with stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 12 months or less)

•PDFF of ≥ 8%

•Male or female, aged 10 to <21 years at the day of randomization, in puberty (pubertal stage will be assessed by pediatric Endocrinologists Dr. Samuels and Dr. Hu) (girls and boys: Tanner stage II-IV); girls who begin menstruating must have a negative pregnancy test during the study

•Weight ≥ 54kg

•BMI ≥ 85% but ≤ 40 kg/m2

•Good general health (normal kidney function, amylase, and lipase levels)

•Informed consent from a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities (trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial)

•Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol.

Exclusion criteria

•Known or suspected hypersensitivity to trial product(s) or related products.

•Receipt of any investigational medicinal product within 30 days before screening.

•Prepubertal participants (Tanner stage 1)

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.

•Having a diagnosis of:

–Type 1 diabetes o Maturity onset diabetes of the young (MODY) o History or presence of Pancreatitis (acute or chronic) o Presence of endocrinopathies (e.g., Cushing syndrome) o Cardiac, renal or pulmonary or other chronic illness o Known history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG, or new clinically significant arrhythmias or conduction delays on ECG identified at visit 1) o Family or personal history of MEN type 2 or medullary thyroid carcinoma (family is defined as a first-degree relative)o Any other disorder which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol

•Any laboratory safety parameter at screening outside the below extended laboratory ranges: o Baseline creatinine >1.0mg o Hypertriglyceridemia)(>500 mg/dl)

–Calcitonin equal or above 50 ng/L at screening o Body Mass Index (BMI) ≤ 25.0 at the screening visit o ALT ≥5 times the upper normal limit (UNL) o Creatinine >UNL for age in children unless renal function is proven normal by further assessments at the discretion of the investigator

•Known hypoglycemic unawareness.

•Recurrent severe hypoglycemic episodes within the last year as judged by the investigator.

•Uncontrolled hypertension treated or untreated >99th percentile for age and gender in children and adolescents.

•Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening.

•Taking medication, based on the investigator's judgement, that may cause significant weight gain or loss (e.g., antipsychotic, steroid, anti-obesity medication).

•Presence or history of malignant neoplasm within 5 years prior to the day of screening.Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

•Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.

Mental health:

•History of major depressive disorder within 2 years before screening

•Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)

•A Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at screening

•A lifetime history of suicidal attempt

•Suicidal behavior within 30 days before screening

•Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity

•Rating Scale (C-SSRS) within the past 30 days before screening

•Participants with confirmed diagnosis of bulimia nervosa disorder

Endpoints (31)

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

Cardiometabolic biomarkers

MASH / liver

Other (unclassified)

Glycemic / diabetes

15 endpoints

Primary/protocol endpoint

Change in Oral Disposition Index (oDI)

Time frame:Baseline and 6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Oral glucose tolerance test (OGTT) derived biomarkers: oDI

Time frame:Baseline and 9 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in OGTT derived biomarkers: fasting insulin

Time frame:Baseline and 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in OGTT derived biomarkers: fasting insulin

Time frame:Baseline and 9 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in OGTT derived biomarkers: c-peptide

Time frame:Baseline and 6 months

ratio, improvement

Secondary/protocol endpoint

Change in OGTT derived biomarkers: c-peptide

Time frame:Baseline and 9 months

ratio, improvement

Secondary/protocol endpoint/low confidence

Change in OGTT derived biomarkers: fasting c-peptide

Time frame:Baseline and 6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in OGTT derived biomarkers: fasting c-peptide

Time frame:Baseline and 9 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Time to glucose peak

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Time to glucose peak

Time frame:6 months

descriptive

Secondary/protocol endpoint

Time to glucose peak

Time frame:9 months

descriptive

Secondary/protocol endpoint/low confidence

Glucagon levels

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Glucagon levels

Time frame:9 months

descriptive

Secondary/protocol endpoint/low confidence

Incretin effect

Time frame:6 months

ratio, descriptive

Secondary/protocol endpoint/low confidence

Incretin effect

Time frame:9 months

ratio, descriptive

MASH / liver

7 endpoints

Primary/protocol endpoint

Change in Protein Density Fat Fraction (PDFF)

Time frame:Baseline and 6 months

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Protein Density Fat Fraction (PDFF)

Time frame:Baseline and 9 months

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Fractional rates of de Novo Lipogenesis (DNL)

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Fractional rates of de Novo Lipogenesis (DNL)

Time frame:6 months

descriptive

Secondary/protocol endpoint/low confidence

Fractional rates of de Novo Lipogenesis (DNL)

Time frame:9 months

descriptive

Other/protocol endpoint

Changes in liver fibrosis

Time frame:6 months

change from baseline, improvement

Other/protocol endpoint

Changes in liver fibrosis

Time frame:9 months

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Total cholesterol

Time frame:6 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Total cholesterol

Time frame:9 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

LDL cholesterol

Time frame:6 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

LDL cholesterol

Time frame:9 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

HDL cholesterol

Time frame:6 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

HDL cholesterol

Time frame:9 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Triglycerides

Time frame:6 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Triglycerides

Time frame:9 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Glucagon levels

Time frame:6 months

descriptive

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.