Recruiting
Phase 1
Phase 2

VV-14300

Sponsor:

Kriya Therapeutics, Inc.

Code:

NCT07831798

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

VV-14300

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT07831798

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Recurrent diabetic ketoacidosis (2 or more events in the 12 months prior to Screening).
  • 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.
  • 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.
  • Known hypersensitivity to tocilizumab, or 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

Study Design

Enrollment

29 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 - Low dose

VV-14300 (low dose) will be administered via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300 dosing to reduce the risk of immune responses.

experimental: Part 1 - High dose

VV-14300 (high dose) will be administered via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300 dosing to reduce the risk of immune responses.

experimental: Part 2 - Dose Expansion

A single dose of VV-14300 at the dose selected from Part 1 will be administered via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300 dosing to reduce the risk of immune responses.

Interventions

VV-14300

VV-14300 will be administered via ultrasound-guided intramuscular injections

Primary outcome measure

  • Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs [ Time Frame: 52 Weeks ]
  • Change from Baseline in blood glucose by as measured by continuous glucose monitoring (CGM) [ Time Frame: 8 Weeks ]
  • Change from Baseline in blood glucose as measured by hemoglobin A1c (HbA1c) level [ Time Frame: 8 Weeks ]
  • Change from Baseline in blood glucose as measured by fructosamine level [ Time Frame: 8 Weeks ]
  • Change from Baseline in blood glucose as measured by mixed meal tolerance test (MMTT) [ Time Frame: 8 Weeks ]
  • Mean change from Baseline in HbA1c [ Time Frame: 26 Weeks ]

Central Contacts and Locations

Central contacts

VP, Medical Affairs

984-884-5058clinicaltrials@kriyatx.com

Locations

Kriya Clinical Trial Site

Recruiting

Toronto, Canada

Contacts

VP, Medical Affairs

1-984-884-5058clinicaltrials@kriyatx.com

More Information

Sponsor

Kriya Therapeutics, Inc.

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Kriya Therapeutics, Inc. on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.