Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-01 @ 1:58 AM
Study NCT ID:
NCT04838405
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2021-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events as assessed by self-report', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'Safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration versus time curve (AUC)', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'PK AUC'}, {'measure': 'Maximum observed drug concentration (Cmax)', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'PK Cmax'}, {'measure': 'Elimination half-life', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'PK t1/2'}, {'measure': 'Change in mean body weight', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'PD body weight'}, {'measure': 'Change in mean glucose levels', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'PD glucose'}, {'measure': 'Change in mean insulin levels', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'PD insulin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://carmot-therapeutics.us/', 'label': 'Carmot Therapeutics, Inc.'}]}, 'descriptionModule': {'briefSummary': 'This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females\n* 18-65 years old, inclusive\n* BMI 27.0-40.0, inclusive\n* Stable body weight for 2 months\n\nExclusion Criteria:\n\n* Significant medical history\n* Uncontrolled hypertension\n* History of malignancy'}, 'identificationModule': {'nctId': 'NCT04838405', 'briefTitle': 'A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carmot Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CT-388-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-388', 'description': 'SC dose of CT-388', 'interventionNames': ['Drug: CT-388']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'SC dose of placebo matching CT-388 dose', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CT-388 Optional', 'description': 'SC dose of CT-388', 'interventionNames': ['Drug: CT-388']}, {'type': 'EXPERIMENTAL', 'label': 'CT-388 MD', 'description': 'SC dose of CT-388', 'interventionNames': ['Drug: CT-388']}], 'interventions': [{'name': 'CT-388', 'type': 'DRUG', 'description': 'Synthetic Peptide', 'armGroupLabels': ['CT-388', 'CT-388 MD', 'CT-388 Optional']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Carmot Clinical Research Unit 101', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '66260', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Carmot Clinical Research Unit 105', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Carmot Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmot Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Carmot Australia First Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}