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Type 1 Diabetes MellitusPhase 1/2PROGRESSNCT07829302

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

A Phase 1/2 study testing VV-14300 and VV-14299 in people with Type 1 Diabetes Mellitus, run by Kriya Therapeutics, Inc. at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
VV-14300 and VV-14299
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteAustralia
Study dates
Oct 2026to Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

VP, Medical Affairs contact

984-884-5058

clinicaltrials@kriyatx.com

Australia1 site, 1 recruiting

  • Kriya Clinical Trial Site

    Melbourne

    VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com

    Recruiting

Other trials in Australia

About this study

Official title: 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

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.

Being tested
VV-14300, VV-14299
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VV-14300Genetic

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

  • VV-14299Genetic

    VV-14299 will be co-administered with VV-14300 via ultrasound-guided intramuscular injections.

Study groups in NCT07829302
Study groupRoleWhat they receive
Part 1 - Cohort 1 (VV-14300, single dose)ExperimentalA single dose of VV-14300 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.
Receives: Genetic: VV-14300
Part 1 - Cohort 2 (VV-14300, single dose + VV-14299, low dose)ExperimentalThe same dose of VV-14300 from Cohort 1 will be co-administered with VV-14299 (low dose) via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300/VV-14299 dosing to reduce the risk of immune responses.
Receives: Genetic: VV-14300; Genetic: VV-14299
Part 1 - Cohort 3 (VV-14300, single dose + VV-14299, high dose)ExperimentalThe same dose of VV-14300 from Cohort 1 will be co-administered with VV-14299 (high dose) via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300/VV-14299 dosing to reduce the risk of immune responses.
Receives: Genetic: VV-14300; Genetic: VV-14299
Part 2 - Dose ExpansionExperimentalThe same dose of VV-14300 from Cohort 1 will be co-administered with VV-14299 at the dose selected from Part 1 via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300/VV-14299 dosing to reduce the risk of immune responses.
Receives: Genetic: VV-14300; Genetic: VV-14299

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs

    Safety of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  2. Change from Baseline in blood glucose as measured by continuous glucose monitoring (CGM)

    Efficacy of VV-14299 and/or VV-14300 (Part 1)

    Measured: 16 Weeks

  3. Change from Baseline in blood glucose as measured by hemoglobin A1c (HBA1c) level

    Efficacy of VV-14299 and/or VV-14300 (Part 1)

    Measured: 16 Weeks

  4. Change from Baseline in blood glucose as measured by fructosamine level

    Efficacy of VV-14299 and/or VV-14300 (Part 1)

    Measured: 16 Weeks

  5. Change from Baseline in blood glucose as measured by mixed meal tolerance test (MMTT)

    Efficacy of VV-14299 and/or VV-14300 (Part 1)

    Measured: 16 Weeks

  6. Mean change from Baseline in HbA1c levels

    Efficacy of VV-14299 and/or VV-14300 (Part 2)

    Measured: 26 Weeks

Secondary outcomes (16)

  1. Mean change from Baseline in HbA1c levels

    Efficacy of VV-14299 and/or VV-14300

    Measured: 16, 26 (Part 1), and 52 Weeks

  2. Change from Baseline in time-in-range derived from CGM data

    Efficacy of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  3. Change from Baseline in mean glucose concentration derived from CGM data

    Efficacy of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  4. Change from Baseline in Glucose Management Indicator (GMI) derived from CGM data

    Efficacy of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  5. Change from Baseline in glycemic variability (coefficient of variation) derived from CGM data

    Efficacy of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  6. Change from Baseline in total daily insulin dose (basal and bolus)

    Efficacy of VV-14299 and/or VV-14300 (insulin-sparing effect)

    Measured: 52 Weeks

  7. Change from Baseline in average insulin boluses per day

    Efficacy of VV-14299 and/or VV-14300 (insulin-sparing effect)

    Measured: 52 Weeks

  8. Change from Baseline in blood glucose by mixed meal tolerance test (MMTT)

    Efficacy of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  9. Change from Baseline in blood glucose by fructosamine level

    Efficacy of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  10. Change from Baseline in body weight

    Safety of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  11. Change from Baseline in fasting lipid levels

    Safety of VV-14299 and/or VV-14300

    Measured: 52 Weeks

  12. 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)

    Humoral immune response to VV-14299 and/or VV-14300

    Measured: 52 Weeks

  13. 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

    Cellular immune response to VV-14299 and/or VV-14300

    Measured: 52 Weeks

  14. VV-14300 vector levels in biological samples

    Vector shedding of VV-14300 in serum, nasal mucus, urine, semen, feces, saliva (Part 1)

    Measured: 52 Weeks

  15. VV-14299 vector levels in biological samples

    Vector shedding of VV-14299 in serum, nasal mucus, urine, semen, feces, saliva (Part 1)

    Measured: 52 Weeks

  16. VV-14299 protein levels in serum

    Vector-mediated transgene expression

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07829302
Sponsor's protocol ID
KRIYA-839-101
Acronym
PROGRESS
Status last verified
Oct 2026
First submitted
31 Aug 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VV-14300 and VV-14299 in people with Type 1 Diabetes Mellitus, run by Kriya Therapeutics, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact VP, Medical Affairs (984-884-5058, clinicaltrials@kriyatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs (time frame: 52 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07829302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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