Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT06062069
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2023-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of CT-868 in Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.', 'timeFrame': 'at Day 1 to Week 16'}, {'measure': 'Time in hypoglycemia as per CGM metrics.', 'timeFrame': 'at Day 1 to Week 16'}, {'measure': 'Time in hyperglycemia as per CGM metrics.', 'timeFrame': 'at Day 1 to Week 16'}], 'primaryOutcomes': [{'measure': 'Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline', 'timeFrame': 'at Day 1 to Week 16'}], 'secondaryOutcomes': [{'measure': 'Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline', 'timeFrame': 'at Day 1 to Weeks 4, 8, and 12'}, {'measure': 'To assess the percentage of participants achieving HbA1c of <7.0%.', 'timeFrame': 'at Week 16'}, {'measure': 'To assess the percentage of participants achieving HbA1c of ≤6.5%.', 'timeFrame': 'at Week 16'}, {'measure': 'To assess the percentage of participants achieving HbA1c of <5.7%.', 'timeFrame': 'at Week 16'}, {'measure': 'Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.', 'timeFrame': 'at Day 1 to Week 16'}, {'measure': 'Change in insulin doses from baseline when comparing CT-868 to placebo.', 'timeFrame': 'at Day 1 to Weeks 8 and 16'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obese', 'Type 1 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://carmot.us/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or older at the time of signing informed consent\n* Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit\n* Body mass index greater than or equal to27.0 kg/m2\n* Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit\n\nExclusion Criteria:\n\n* Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM\n* Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit\n* Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit'}, 'identificationModule': {'nctId': 'NCT06062069', 'briefTitle': 'A Study of CT-868 in Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carmot Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CT-868-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-868 Low Dose', 'description': 'Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks.', 'interventionNames': ['Drug: CT-868', 'Device: CT-868 Pen Injector']}, {'type': 'EXPERIMENTAL', 'label': 'CT-868 Medium Dose', 'description': 'Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks.', 'interventionNames': ['Drug: CT-868', 'Device: CT-868 Pen Injector']}, {'type': 'EXPERIMENTAL', 'label': 'CT-868 High Dose', 'description': 'Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks.', 'interventionNames': ['Drug: CT-868', 'Device: CT-868 Pen Injector']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CT-868 Placebo', 'description': 'Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks.', 'interventionNames': ['Device: CT-868 Pen Injector', 'Drug: CT-868 Pen Injector, Placebo']}], 'interventions': [{'name': 'CT-868', 'type': 'DRUG', 'description': 'CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.', 'armGroupLabels': ['CT-868 High Dose', 'CT-868 Low Dose', 'CT-868 Medium Dose']}, {'name': 'CT-868 Pen Injector', 'type': 'DEVICE', 'description': 'The CT-868 pen injector is a multi-dose, single-participant, disposable pen.', 'armGroupLabels': ['CT-868 High Dose', 'CT-868 Low Dose', 'CT-868 Medium Dose', 'CT-868 Placebo']}, {'name': 'CT-868 Pen Injector, Placebo', 'type': 'DRUG', 'description': 'The placebo pen injector is identical and contains the same ingredients except for CT-868.', 'armGroupLabels': ['CT-868 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Physician Network Clinical Research Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Headlands Research- AMCR', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Barbara Davis Center for Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Endocrinology Diabetes and Thyroid Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32822', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health Science Clinic, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research Institute', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Diabetes and Endocrinology Research Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Health Research Institute - Washington Hospital Center', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Health Sciences at MAHEC', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lucas Research, Inc', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes and Endocrinology, P.A', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Institute of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes & Glandular Disease Clinic, P.A.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Consano Clinical Research', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '78596', 'city': 'Weslaco', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Valley Clinical Research, LLC', 'geoPoint': {'lat': 26.15952, 'lon': -97.99084}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Carmot Therapeutics, Inc., a member of the Roche Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmot Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}