VV-14300 for the Treatment of Type 1 Diabetes

A vizsgálat adatai

Ki végzi

Kriya Therapeutics, Inc.

Azonosító

NCT07831798

A regiszteradat frissítve

2026. október 5.

Eredeti leírás

This study is testing VV-14300 in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system. VV-14300 is an investigational gene therapy that is injected into muscle and is designed to help remove excess sugar from the blood.A teljes eredeti leírásKevesebb

A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of VV-14300 (Adeno-associated Virus Vector-mediated Glucokinase) in Adults With Long-Standing Type 1 Diabetes and Suboptimal Glycemic Control Using an Automated Insulin Delivery (AID) System

This study is testing VV-14300 in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system. VV-14300 is an investigational gene therapy that is injected into muscle and is designed to help remove excess sugar from the blood.

Bevonási feltételek: Able to provide signed informed consent; 18 to 65 years of age (inclusive) at Screening; Body mass index (BMI) of 20.0 to <30.0 kg/m²; Clinical diagnosis of Type 1 Diabetes 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; Suboptimal glycemic control (HbA1c >7% and <10%), and on a stable insulin regimen at Screening; Adequate kidney function (estimated glomerular filtration rate [eGFR] >60 mL/min/1.73m²) at Screening; 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; Agree to refrain from donating blood, plasma, platelets, eggs, or sperm during the 12-month Post-Treatment Follow-up Period; Willing and able to complete all study visits, procedures, and required use of study-provided monitoring devices for the duration of the study.

Kizáró feltételek: Recurrent diabetic ketoacidosis (2 or more events in the 12 months prior to Screening); Vaccination within 30 days prior to dosing or planned vaccination within 8 weeks post-dosing; History of bariatric surgery within the 12 months prior to Screening; Participation in another investigational drug or biologic trial within 6 months prior to Screening, or participation in any previous gene therapy trial; 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; 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; 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; Significant history of alcohol or drug abuse, or positive alcohol breath test or urine drug screen at the Screening or Run-in visit; 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; History of trauma to, or other findings affecting the suitability of, the muscles intended for study intervention administration; Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically significant ECG abnormality; 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; 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]); Known hypersensitivity to tocilizumab, or Screening laboratory findings indicating undue risk of a tocilizumab-related adverse event; Pregnant or breastfeeding; 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; Impaired awareness of hypoglycemia.

ClinicalTrials.gov NCT07831798