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Not yet recruitingPhase 2

GLP-1 RA for Stage 1 Type 1 Diabetes

Leveraging Semaglutide for Preservation of Beta Cell Function and Restoration of Alpha Cell Function

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will evaluate this by measuring stimulated glucagon levels via a 2 hour, 7-point OGTT and by measuring pre and post OGTT liver glycogen content via liver MRI at baseline and after 12 months of semaglutide therapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how semaglutide, a GLP-1 medicine, affects insulin and other hormones in people with stage 1 type 1 diabetes. It aims to see if the medicine can protect cells that make insulin and delay stage 2 type 1 diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage 1 type 1 diabetes.
  • Have a screening glucose drink test showing a weak or missing early insulin response, but no abnormal blood sugar suggesting stage 2 or 3 type 1 diabetes.

Who can't join

  • Have had an allergic reaction, including a life-threatening reaction, to a GLP-1 medicine.
  • Already take a GLP-1 medicine.
  • Have had weight-loss surgery.
  • Have a personal or family history of cancer, such as medullary thyroid cancer, a type of thyroid cancer.
  • Have had pancreatitis (swelling of the pancreas), or have gene changes that raise the risk of it.
  • Have had severely low blood sugar within 3 months before joining the study.
  • Are pregnant, breastfeeding, planning to become pregnant, or not using enough birth control to prevent pregnancy.
  • Have a body mass index (BMI, a measure of weight compared with height) below 18.5 as an adult, or below the 5th percentile as a child.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

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