Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:40 PM
Study NCT ID:
NCT07430332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GLP-1 RA for Stage 1 Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-peptide area under the curve', 'timeFrame': '12 months', 'description': 'measured levels of c-peptide during oral glucose tolerance test'}, {'measure': 'C-peptide area under the curve (AUC)', 'timeFrame': '12 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Stimulated incretin levels', 'timeFrame': '12 months', '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.'}, {'measure': 'Glucagon secretion', 'timeFrame': '12 months', 'description': 'Glucagon secretion in response to oral glucose tolerance test will be measured and compared at baseline and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLP-1 RA', 'Semaglutide', 'Stage 1 type 1 diabetes', 'type 1 diabetes prevention'], 'conditions': ['Stage 1 Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '36084852', 'type': 'BACKGROUND', 'citation': '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': '33662334', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study aims to evaluate the effects of semaglutide on pancreatic beta and alpha cell function in individuals with stage 1 type 1 diabetes (T1D). Despite having euglycemia, individuals with stage 1 T1D may already exhibit loss of the first phase insulin response (FPIR). Incretins play a significant role in FPIR through their effects on insulin secretion and sensitivity, offering a potential therapeutic target for restoration of FPIR. Furthermore, prior studies have demonstrated that individuals with T1D exhibit inappropriate glucagon release in response to glucose, worsening glycemic control. Not only do incretins affect beta cells, but they can also inhibit glucagon secretion, potentially attenuating this dysregulated glucagon response. Studies have shown safety of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with T1D and their beneficial effects on reducing inflammation and preserving beta cell function. However, no studies have evaluated the effects of GLP-1 RAs on beta cell function and glucagon secretion in stage 1 type 1 diabetes to date. As incretins can inhibit glucagon secretion, we hypothesize that semaglutide may attenuate dysregulated glucagon responses, thereby improving glycemic control and potentially altering disease progression. To evaluate the effects of semaglutide in stage 1 T1D, we propose the following aims:\n\n1. Define the effect of semaglutide on beta cell function. We hypothesize that semaglutide may restore FPIR and preserve beta cell function. A 2 hour, 7-point oral glucose tolerance test (OGTT) at baseline and after 12 months of semaglutide will be used to evaluate FPIR and beta cell function through serial measurements of insulin, pro-insulin, C-peptide, glucose, GLP-1, and GIP.\n2. Identify the effect of semaglutide on glucagon secretion in response to glucose. We hypothesize that semaglutide will suppress glucose-stimulated glucagon release. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 1 Type 1 Diabetes\n* Screening OGTT with impaired or loss of first phase insulin secretion but no dysglycemia to suggest stage 2 or stage 3 type 1 diabetes\n\nExclusion Criteria:\n\n* History of anaphylaxis or allergies to GLP-1 receptor agonists\n* Already on a GLP-1 receptor agonist\n* History of bariatric surgery\n* Personal or family history of cancer such as medullary thyroid cancer\n* Personal history of pancreatitis or pathogenic variants associated with increased risk of pancreatitis\n* Severe hypoglycemia within 3 months of study enrollment\n* Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures\n* Adult individuals with BMI \\< 18.5 kg/m2 and pediatric participants with BMI \\< 5th percentile'}, 'identificationModule': {'nctId': 'NCT07430332', 'briefTitle': 'GLP-1 RA for Stage 1 Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Leveraging Semaglutide for Preservation of Beta Cell Function and Restoration of Alpha Cell Function', 'orgStudyIdInfo': {'id': '2026-0116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide or Placebo Treatment', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Randomized to placebo or semaglutide', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Study participants will be randomized to either placebo or semaglutide treatment for 12 months', 'armGroupLabels': ['Semaglutide or Placebo Treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Randomized to either placebo or semaglutide.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Lily Deng, MD', 'role': 'CONTACT', 'email': 'lily.deng@cchmc.org', 'phone': '513-636-0002'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Lily Deng, MD', 'role': 'CONTACT', 'email': 'lily.deng@cchmc.org', 'phone': '513-636-0002'}, {'name': 'Mansa Krishnamurthy, MD', 'role': 'CONTACT', 'email': 'mansa.krishnamurthy@cchmc.org', 'phone': '513-636-4744'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}