Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 6:18 PM
Study NCT ID:
NCT06694935
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], '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': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'Baseline Day 1 up to Week 12'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': '12 Weeks', 'description': 'Change in HbA1c percentage from baseline with QX1206'}, {'measure': 'Fasting plasma glucose (FPG)', 'timeFrame': '12 Weeks', 'description': 'Change in FPG mg/dL from baseline with QX1206'}, {'measure': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': '12 Weeks', 'description': 'Change in the HOMA-IR from baseline with QX1206'}, {'measure': 'Fasting insulin', 'timeFrame': '12 Weeks', 'description': 'Change in fasting insulin pmol/L from baseline with QX1206'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Non-Alcoholic Fatty Liver Disease (NAFLD)']}, 'descriptionModule': {'briefSummary': 'This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent must be obtained and documented\n* 18 years of age and \\< 65 years old\n* BMI ≥ 18 kg/m\\^2 and \\< 45 kg/m\\^2\n* T2DM diagnosed per 2021 American Diabetes Association criteria\n* Diagnosis of NAFLD\n* For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study\n* Women of child-bearing potential (WOCBP) must have a negative pregnancy test\n* Serum creatinine \\< 1.5×ULN or creatinine clearance ≥ 60 ml/min\n* Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Patients with an active, serious medical disease that limit activities of daily living\n* Patients with current, significant alcohol consumption or a history of significant alcohol consumption\n* Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:\n* Fasting triglycerides \\> 500 mg/dL\n* Fasting direct LDL-C \\> 190 mg/dL\n* AST \\> 5.0 × upper limit of normal (ULN)\n* ALT \\> 5.0 × ULN\n* Alkaline phosphatase (ALP) ≥ 2 × ULN\n* HbA1c \\> 10.5%\n* Fasting plasma glucose (FPG) \\> 240 mg/dL (13.3 mmol/L)\n* Platelets count \\< 140,000/mm\\^3\n* Patient takes drugs historically associated with NAFLD and other known hepatotoxins\n* Treatment with drugs (e.g., vitamin E \\> 400 IU/day) or herbal supplements with potential anti-NAFLD effect'}, 'identificationModule': {'nctId': 'NCT06694935', 'briefTitle': 'A Phase 1b Study of QX1206 in T2DM Patients With NAFLD', 'organization': {'class': 'INDUSTRY', 'fullName': '1Globe Health Institute'}, 'officialTitle': 'A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'T2DM-QX1206-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QX1206', 'interventionNames': ['Drug: QX1206']}], 'interventions': [{'name': 'QX1206', 'type': 'DRUG', 'description': 'QX1206 will be administered orally before bedtime', 'armGroupLabels': ['QX1206']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'arlene.vinas@centricityresearch.com', 'phone': '416-645-2929, Ext 9232'}], 'facility': 'Centricity Research Toronto LMC.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': '1Globe Health Institute', 'role': 'CONTACT', 'email': 'T2DM-QX1206-1_Study@1globe-usa.com', 'phone': '617-649-1157'}], 'overallOfficials': [{'name': 'Andrew Keates, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': '1Globe Health Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '1Globe Health Institute', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}