Semaglutide for people at an early stage of type 1 diabetes
Tests semaglutide against placebo in people with early-stage type 1 diabetes.
Key facts
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Where
- Cincinnati, United StatesSee the site
- Trial code
- Registry title
- GLP-1 RA for Stage 1 Type 1 Diabetes
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 15 people, planned
- Starts
- 1 Sept 2027
- Expected to end
- 1 Jan 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Semaglutide
- Placebo
- Record updated
- 24 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with stage 1 type 1 diabetes. It tests whether semaglutide can protect insulin-making beta cells and delay stage 2 type 1 diabetes.
- Age
- 12 Years to 70 Years
- Sex
- All sexes can join.
- Disease stage
- Stage 1 type 1 diabetes. A screening glucose tolerance test (OGTT) shows impaired or lost first-phase insulin release. There are no high blood sugar signs of stage 2 or stage 3.
- Earlier treatment
- People already taking a GLP-1 receptor agonist cannot join. People who have had bariatric surgery cannot join.
- Biomarker or test result
- A screening OGTT with impaired or loss of first phase insulin secretion, but no dysglycemia suggesting stage 2 or stage 3 type 1 diabetes.
Main reasons for not taking part
- Past severe allergic reaction (anaphylaxis) or allergy to GLP-1 receptor agonists
- Personal or family history of cancer such as medullary thyroid cancer
- Personal history of pancreatitis or gene changes that raise the risk of pancreatitis
- Severe low blood sugar within 3 months of joining
- Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of anaphylaxis or allergies to GLP-1 receptor agonists
- 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
- Already on a GLP-1 receptor agonist
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 70 years old?
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Lily Deng, MDNot yet recruiting
About the trial
What the trial wants to find out
This study seeks to evaluate the hormone responses of insulin, c-peptide, glucagon, and incretins to semaglutide, a GLP-1 receptor agonist therapy, in individuals with stage 1 type 1 diabetes. The goal of this study is to see if semaglutide can protect beta cell function in this group of people and delay the progression to stage 2 type 1 diabetes.
The 2 groups in the trial
- Semaglutide or Placebo TreatmentTreatment being tested
Treatment: Semaglutide
- PlaceboPlacebo, for comparison
Randomized to placebo or semaglutide
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Leveraging Semaglutide for Preservation of Beta Cell Function and Restoration of Alpha Cell Function
- Plain-language title
- Semaglutide for people at an early stage of type 1 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07430332, who can take part
- Record updated
- 24 February 2026