GLP-1 RA for Stage 1 Type 1 Diabetes

This study is looking at whether a medication called semaglutide can help protect the cells in your pancreas that make insulin (beta cells) if you have Stage 1 Type 1 Diabetes. Stage 1 means you have signs of Type 1 Diabetes but your blood sugar levels are still normal. Researchers want to see if semaglutide can delay the disease from getting worse. You would either receive semaglutide or a placebo (an inactive substance) for 12 months. The main way they will measure success is by looking at your C-peptide levels, which show how much insulin your body is making, after 12 months. This study is for people aged 12 to 70 who have Stage 1 Type 1 Diabetes, specifically those with impaired first phase insulin secretion but no signs of Stage 2 or 3 diabetes.

Study design: This is an interventional study, meaning participants will receive a specific treatment. About 15 people will be randomly assigned to either receive semaglutide or a placebo.
What's involved: Participants will receive either semaglutide or a placebo treatment for 12 months. The study will measure C-peptide levels at 12 months.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 12 months, with C-peptide levels measured at that time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

GLP-1 RA for Stage 1 Type 1 Diabetes

Not Yet Recruiting

PHASE2Ages 12–70InterventionalPrevention

Children's Hospital Medical Center, Cincinnati

~15 participants

Updated 2026-02-24 on ClinicalTrials.gov

What's tested:SemaglutidePlacebo

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

C-peptide area under the curve

Measured over 12 months

+1 more outcome measured

Conditions

Stage 1 Diabetes Mellitus, Type 1

Where it's being run

1 sites across 1 states

Ohio1

Who to contact

Lily Deng, MD

[email protected]

513-636-0002

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Stage 1 Type 1 Diabetes

Screening OGTT with impaired or loss of first phase insulin secretion but no dysglycemia to suggest stage 2 or stage 3 type 1 diabetes

Exclusion

History of anaphylaxis or allergies to GLP-1 receptor agonists

Already on a GLP-1 receptor agonist

History of bariatric surgery

Personal or family history of cancer such as medullary thyroid cancer

Personal history of pancreatitis or pathogenic variants associated with increased risk of pancreatitis

Severe hypoglycemia within 3 months of study enrollment

Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures

Adult individuals with BMI \< 18.5 kg/m2 and pediatric participants with BMI \< 5th percentile

What this trial measures

C-peptide area under the curve12 months
measured levels of c-peptide during oral glucose tolerance test
C-peptide area under the curve (AUC)12 months
C-peptide area under the curve levels will be calculated from stimulated C-peptide levels in an oral glucose tolerance test at baseline and after treatment with placebo or semaglutide.

Trialytics