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Trial · Interventional

Not yet recruitingPhase 2Registry data

GLP-1 RA for Stage 1 Type 1 Diabetes

NCTNCT07430332 (opens ClinicalTrials.gov in a new tab)Other id2026-0116
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 2
Enrollment
15 participants (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
1 Sept 2027 (estimated)
Primary completion
1 Jun 2029 (estimated)
Completion
1 Jan 2030 (estimated)
First posted
24 Feb 2026
Last update posted
24 Feb 2026
Conditions
Stage 1 Diabetes Mellitus, Type 1

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20272028202920302031
  1. Ph 2

    GLP-1 RA for Stage 1 Type 1 Diabetes

    NCT07430332

    est. 1 Sept 2027 to est. 1 Jan 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Semaglutide or Placebo Treatment

  • Placebo comparator

    Placebo

    Randomized to placebo or semaglutide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. C-peptide area under the curve

    Time frame · 12 months

    Registry description

    measured levels of c-peptide during oral glucose tolerance test

  2. C-peptide area under the curve (AUC)

    Time frame · 12 months

    Registry description

    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.

Secondary outcomes(2)

  1. Stimulated incretin levels

    Time frame · 12 months

    Registry description

    Stimulated incretin levels will be measured via oral glucose tolerance test at baseline and after treatment. The time to peak level and peak level will be compared.

  2. Glucagon secretion

    Time frame · 12 months

    Registry description

    Glucagon secretion in response to oral glucose tolerance test will be measured and compared at baseline and after treatment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

10 results

Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial.

von Herrath et al. 2021The lancet. Diabetes & endocrinologycited by 153

PMID 33662334DOI 10.1016/s2213-8587(21)00019-xPUB-33662334

Rights unknown10 results
Source linkSee results (10)

More studies

1 study on this page

PubMed tag: none · 2022

Liraglutide protects β-cells in novel human islet spheroid models of type 1 diabetes.

Yesildag et al. 2022Clinical immunology (Orlando, Fla.)cited by 12

PMID 36084852DOI 10.1016/j.clim.2022.109118PUB-36084852

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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