Skip to content
TrialMatch
Sign up
Recruiting Phase 1 / Phase 2

VV-14299 and VV-14300 for the Treatment of Type 1 Diabetes

Create a profile to match View the full record on ClinicalTrials.gov

About this study

This study is testing VV-14299 and VV-14300 or VV-14300 alone 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-14299 and VV-14300 are investigational gene therapies that are injected into muscle and are designed to work together to help remove excess sugar from the blood.

Condition
Type 1 Diabetes Mellitus
Tested
VV-14300, VV-14299
Sponsor
Kriya Therapeutics, Inc.

Who can join

Age
18 to 65 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Maximum age: 65 years
  • Study condition: Type 1 Diabetes Mellitus
  • 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 (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.
  • 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.
  • 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 study-provided monitoring devices for the duration of the study.

Exclusion 17

  • 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.
  • Pregnant or breastfeeding.
  • 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.
  • Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically significant ECG abnormality.
  • Significant history of alcohol or drug abuse, or positive alcohol breath test or urine drug screen at the Screening or Run-in visit.
  • 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.
  • Documented anti-AAV1 neutralizing antibody titer above the protocol-specified threshold at Screening.
  • 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.
  • 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 \[e.g., glucagon-like peptide 1 (GLP-1) receptor agonists and/or sodium-glucose cotransport 2 (SGLT2) inhibitors\]).
  • Vaccination within 30 days prior to dosing or planned vaccination within 8 weeks post-dosing.
  • Screening laboratory findings indicating undue risk of a tocilizumab-related adverse event.
  • History of bariatric surgery within the 12 months prior to Screening.
  • History of trauma to, or other findings affecting the suitability of, the muscles intended for study intervention administration.
  • Participation in another investigational drug or biologic trial within 6 months prior to Screening, or participation in any previous gene therapy trial.

Where

1 site, 1 recruiting

Kriya Clinical Trial Site

Melbourne, Australia

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.