{ "data": { "asOf": "2026-10-30T22:25:43.591Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07829302", "title": "VV-14299 and VV-14300 for the Treatment of Type 1 Diabetes", "scientificTitle": "A Phase 1/2, First-in-Human, Adaptive, Model-based, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of VV-14299 and VV-14300 (Adeno-associated Virus Vector-mediated Insulin and Glucokinase) in Adults With Long-Standing Type 1 Diabetes and Suboptimal Glycemic Control Using a Continuous Subcutaneous Insulin Infusion (CSII) Pump", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE1", "PHASE2" ], "conditions": [ "Type 1 Diabetes Mellitus" ], "interventions": [ { "name": "VV-14300", "type": "GENETIC", "description": "VV-14300 will be administered via ultrasound-guided intramuscular injections." }, { "name": "VV-14299", "type": "GENETIC", "description": "VV-14299 will be co-administered with VV-14300 via ultrasound-guided intramuscular injections." } ], "sponsor": { "name": "Kriya Therapeutics, Inc.", "type": "INDUSTRY" }, "locations": [ { "city": "Melbourne", "country": "Australia", "facility": "Kriya Clinical Trial Site" } ], "outcomes": { "other": [], "primary": [ "Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs", "Change from Baseline in blood glucose as measured by continuous glucose monitoring (CGM)", "Change from Baseline in blood glucose as measured by hemoglobin A1c (HBA1c) level", "Change from Baseline in blood glucose as measured by fructosamine level", "Change from Baseline in blood glucose as measured by mixed meal tolerance test (MMTT)", "Mean change from Baseline in HbA1c levels" ], "secondary": [ "Mean change from Baseline in HbA1c levels", "Change from Baseline in time-in-range derived from CGM data", "Change from Baseline in mean glucose concentration derived from CGM data", "Change from Baseline in Glucose Management Indicator (GMI) derived from CGM data", "Change from Baseline in glycemic variability (coefficient of variation) derived from CGM data", "Change from Baseline in total daily insulin dose (basal and bolus)", "Change from Baseline in average insulin boluses per day", "Change from Baseline in blood glucose by mixed meal tolerance test (MMTT)", "Change from Baseline in blood glucose by fructosamine level", "Change from Baseline in body weight", "Change from Baseline in fasting lipid levels", "Change from Baseline in the level of antibodies to AAV vector capsid, VV-14300-expressed transgene product, and VV-14299-expressed transgene product by enzyme-linked immunosorbent assay (ELISA)", "Change from Baseline in interferon-gamma cellular immune response to AAV1 capsid, VV-14300-expressed transgene product, and VV-14299-expressed transgene product by enzyme-linked immunosorbent spot (ELISpot) assay", "VV-14300 vector levels in biological samples", "VV-14299 vector levels in biological samples", "VV-14299 protein levels in serum" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Able to provide signed informed consent.\n* 18 to 65 years of age (inclusive) at Screening.\n* Body mass index (BMI) of 20.0 to \\<30.0 kg/m².\n* Clinical diagnosis of Type 1 Diabetes (T1D) for at least 5 years prior to Screening, currently managed with an Automated Insulin Delivery (AID) system for at least 3 months prior to Screening.\n* Suboptimal glycemic control (C-peptide \\<0.20 ng/mL \\[0.667 nmol/L\\] during a mixed meal tolerance test; HbA1c \\>7% and \\<10%); and on a stable insulin regimen at Screening.\n* Adequate kidney function (estimated glomerular filtration rate \\[eGFR\\] \\>60 mL/min/1.73m²) at Screening.\n* Females of child-bearing potential must have a negative pregnancy test at Screening and prior to dosing; participants must agree to use highly effective contraception during and for at least 12 months after study intervention administration\n* Agree to refrain from donating blood, plasma, platelets, eggs, or sperm during the 12-month Post-Treatment Follow-up Period.\n* Willing and able to complete all study visits, procedures, and required use study-provided monitoring devices for the duration of the study.\n\nExclusion Criteria:\n\n* Type 2 diabetes or other condition requiring exogenous insulin that is not due to autoimmunity, or when insulin delivery is not managed through an AID system.\n* Diabetic complications (e.g., severe/proliferative retinopathy or neuropathy) or a clinically significant medical, cognitive, or psychiatric condition that, in the Investigator's opinion, poses additional risk or would make consistent study follow-up unlikely.\n* Pregnant or breastfeeding.\n* History of malignancy requiring chemotherapy and/or radiation within the 12 months prior to Screening, except for successfully treated non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.\n* Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically significant ECG abnormality.\n* Significant history of alcohol or drug abuse, or positive alcohol breath test or urine drug screen at the Screening or Run-in visit.\n* Plans to implement new strenuous physical activity (e.g., significantly increased running pace/duration, high-intensity interval training, heavy weightlifting, vigorous cycling) during the study.\n* Impaired awareness of hypoglycemia.\n* Documented anti-AAV1 neutralizing antibody titer above the protocol-specified threshold at Screening.\n* Active hepatitis B or C infection, positive HIV serology, or any latent or active infection that would interfere with study procedures or be exacerbated by study medications.\n* Clinically significant abnormal Screening laboratory or other diagnostic findings (including hepatic, hematologic, thyroid, muscle-enzyme, or tuberculosis screening) rendering the participant unsuitable for the study.\n* Current or recent use of medications that could interfere with glucose metabolism or confound study assessments (e.g., glucocorticoids, systemic beta-blockers, growth hormone, or other antidiabetic medications \\[e.g., glucagon-like peptide 1 (GLP-1) receptor agonists and/or sodium-glucose cotransport 2 (SGLT2) inhibitors\\]).\n* Vaccination within 30 days prior to dosing or planned vaccination within 8 weeks post-dosing.\n* Screening laboratory findings indicating undue risk of a tocilizumab-related adverse event.\n* History of bariatric surgery within the 12 months prior to Screening.\n* History of trauma to, or other findings affecting the suitability of, the muscles intended for study intervention administration.\n* Participation in another investigational drug or biologic trial within 6 months prior to Screening, or participation in any previous gene therapy trial.", "maximumAge": "65 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 29 }, "startDate": "2026-10-01", "completionDate": "2029-07-01", "lastUpdated": "2026-10-05T00:00:00.000Z", "firstPosted": "2026-09-21T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07829302" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07829302", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07829302", "sourceUrl": "https://clinicaltrials.gov/study/NCT07829302", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:00.159Z", "payloadSha256": "e67112ef4cc9d9b5cc63e4c0ae3e258ac51af67b98f209dc0ed9314950107fae", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07829302", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07829302", "verifyAt": "https://clinicaltrials.gov/study/NCT07829302", "retrievedAt": "2026-10-28T04:32:00.159Z", "payloadSha256": "e67112ef4cc9d9b5cc63e4c0ae3e258ac51af67b98f209dc0ed9314950107fae", "text": "ClinicalTrials.gov, record NCT07829302 (https://clinicaltrials.gov/study/NCT07829302), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; 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