NCT07430332

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
28mo left

Started Sep 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2027

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 18, 2026

Last Update Submit

February 18, 2026

Conditions

Stage 1 Diabetes Mellitus, Type 1

Keywords

GLP-1 RASemaglutideStage 1 type 1 diabetestype 1 diabetes prevention

Outcome Measures

Primary Outcomes (2)

  • C-peptide area under the curve

    measured levels of c-peptide during oral glucose tolerance test

    12 months

  • C-peptide area under the curve (AUC)

    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.

    12 months

Secondary Outcomes (2)

  • Stimulated incretin levels

    12 months

  • Glucagon secretion

    12 months

Study Arms (2)

Semaglutide or Placebo Treatment

EXPERIMENTAL
Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Randomized to placebo or semaglutide

Drug: Placebo

Interventions

SemaglutideDRUG

Study participants will be randomized to either placebo or semaglutide treatment for 12 months

Semaglutide or Placebo Treatment
PlaceboDRUG

Randomized to either placebo or semaglutide.

Placebo

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

  • Yesildag B, Mir-Coll J, Neelakandhan A, Gibson CB, Perdue NR, Rufer C, Karsai M, Biernath A, Forschler F, Jin PW, Misun PM, Title A, Hierlemann A, Kreiner FF, Wesley JD, von Herrath MG. Liraglutide protects beta-cells in novel human islet spheroid models of type 1 diabetes. Clin Immunol. 2022 Nov;244:109118. doi: 10.1016/j.clim.2022.109118. Epub 2022 Sep 6.

    PMID: 36084852BACKGROUND

  • von Herrath M, Bain SC, Bode B, Clausen JO, Coppieters K, Gaysina L, Gumprecht J, Hansen TK, Mathieu C, Morales C, Mosenzon O, Segel S, Tsoukas G, Pieber TR; Anti-IL-21-liraglutide Study Group investigators and contributors. Anti-interleukin-21 antibody and liraglutide for the preservation of beta-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2021 Apr;9(4):212-224. doi: 10.1016/S2213-8587(21)00019-X. Epub 2021 Mar 1.

    PMID: 33662334BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Lily Deng, MD

CONTACT

513-636-0002lily.deng@cchmc.org

Mansa Krishnamurthy, MD

CONTACT

513-636-4744mansa.krishnamurthy@cchmc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 24, 2026

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)