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Kriya muscle-directed AAV gene therapy (VV-14299 / VV-14300; KRIYA.288)

Kriya Therapeutics

What it is

Kriya has opened two recruiting first-in-human Phase 1/2 trials in September–October 2026: PROGRESS (NCT07829302 in Melbourne, Australia) testing intramuscular VV-14300 (AAV-glucokinase) alone or co-administered with VV-14299 (AAV-insulin), and RELIEVE (NCT07831798 in Canada and New Zealand) testing VV-14300 monotherapy in adults with long-standing T1D on automated insulin delivery. No human outcomes are posted.

Editorial review: .

Most recent recorded citation dates: 2026-10-05; 2026-10-05. Some dates overlap at their stated precision or share the same date. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

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On the horizonEarly evidencegene-therapyaavin-vivoglucokinaseintramuscularOfficial site ↗

Evidence behind this assessment

Key evidence notes. Study results, product eligibility and access answer different questions.

Who was studied?
Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
Benefit or performance
Efficacy: No human efficacy results are posted yet for VV-14299 or VV-14300. Earlier animal work combining insulin and glucokinase cannot establish human efficacy.[5]
Important harms and treatment burden
Safety: First-in-human Phase 1/2 trials (NCT07829302 and NCT07831798) are recruiting with 52-week primary safety endpoints, but no human safety results are posted.[1]
Approval and country access
Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
Follow-up and remaining uncertainty
Durability: Long-lasting glucose control in historical insulin-plus-glucokinase animal experiments does not demonstrate human durability for VV-14299 or VV-14300.[5]

Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.

Editorial score: calculation and evidence

A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.

Default calculation: 12 × 20 + 25 × 20 + 22 × 20 + 22 × 16 + 12 × 12 + 25 × 12 = 1976; divide by total weight 100. Unrounded weighted result: 19.76.

Efficacy12

No human efficacy results are posted yet for VV-14299 or VV-14300. Earlier animal work combining insulin and glucokinase cannot establish human efficacy.[5]

Durability12

Long-lasting glucose control in historical insulin-plus-glucokinase animal experiments does not demonstrate human durability for VV-14299 or VV-14300.[5]

Safety22

First-in-human Phase 1/2 trials (NCT07829302 and NCT07831798) are recruiting with 52-week primary safety endpoints, but no human safety results are posted.[1]

Eligibility breadth25

Both PROGRESS and RELIEVE enroll adults aged 18–65 with T1D for at least 5 years, BMI 20.0 to under 30.0 kg/m², and suboptimal glycemic control on an AID system.[1]

Maturity22

Two first-in-human Phase 1/2 trials (PROGRESS NCT07829302 in Australia and RELIEVE NCT07831798 in Canada/New Zealand, estimated n=29 each) are now registered and recruiting on ClinicalTrials.gov as of October 2026.[1]

Immunosuppression-free25

Intramuscular AAV1 delivery of insulin and glucokinase genes avoids chronic transplant calcineurin inhibitors (typically using only transient peri-dosing corticosteroids for AAV capsid immunity), but human therapeutic performance without immunosuppression has not yet been reported.

Immunosuppression-free is scored here, as it is for cell replacement and encapsulation — freeing a therapy from lifelong anti-rejection drugs is the central barrier this whole pillar is trying to clear, so an approach that achieves it must be able to earn credit for it. It is scored on evidence, not intent: a platform designed to avoid immunosuppression but never yet tested at a therapeutic dose scores on what it has shown. Approaches that transplant nothing (in-vivo gene therapy, reprogramming) need no anti-rejection drugs by construction, but they still face the original autoimmune attack — that unresolved risk belongs in this score, not hidden by it.

The full picture

Current programme and registered Phase 1/2 trials

On 21 September 2026 (updated 5 October 2026), Kriya Therapeutics registered two recruiting first-in-human Phase 1/2 trials on ClinicalTrials.gov that clarify the relationship between its glucokinase-only and combined insulin-plus-glucokinase vectors:12

  • PROGRESS (NCT07829302, Melbourne, Australia): An adaptive, model-based dose-escalation study (n=29 estimated, recruiting) evaluating ultrasound-guided intramuscular injections of VV-14300 (AAV vector-mediated glucokinase) alone or co-administered with VV-14299 (AAV vector-mediated insulin) in adults aged 18–65 with T1D for at least 5 years, C-peptide negativity, BMI 20.0 to under 30.0 kg/m², and suboptimal glycemic control on an automated insulin delivery (AID) system. Co-primary endpoints assess 52-week safety alongside 16-week changes in CGM metrics and HbA1c (estimated primary completion July 2029).1
  • RELIEVE (NCT07831798, Canada and New Zealand): A parallel Phase 1/2 adaptive dose-escalation study (n=29 estimated, recruiting) testing VV-14300 (AAV-glucokinase) monotherapy in the same adult AID-user population, with co-primary endpoints of 52-week safety, 8-week CGM metrics, and 16-week HbA1c (estimated primary completion November 2028).2

Kriya's corporate pipeline page also refers to KRIYA.288 as an outpatient intramuscular AAV glucokinase programme.3

Evidence and limits

Earlier reporting used the name KRIYA-839 and cited preclinical animal work combining insulin and glucokinase in skeletal muscle.45 While both VV-14300 monotherapy and VV-14299 + VV-14300 co-administration have now entered human Phase 1/2 recruitment, no human safety or glucose-control results have been posted. Trial registration is not evidence of clinical benefit or insulin independence.12

Coming soon

ETA · First-in-human Phase 1/2 recruiting (NCT07829302, NCT07831798); estimated primary completions 2028–2029

  • →Initial human safety, CGM, and HbA1c readouts from PROGRESS (NCT07829302) and RELIEVE (NCT07831798) · Estimated primary completions November 2028 (RELIEVE) and July 2029 (PROGRESS)

Sources

  1. [1]
    PROGRESS: A Phase 1/2 Study of VV-14299 and VV-14300 in Adults With Long-Standing Type 1 Diabetes (NCT07829302) · Trial registry · 2026-10-05 — Checked 19 October 2026 (first posted 21 September 2026, updated 5 October 2026). Recruiting in Melbourne, Australia; estimated n=29; adults 18–65 with T1D >=5 years on AID/CSII; tests ultrasound-guided intramuscular VV-14300 (AAV-glucokinase) alone or co-administered with VV-14299 (AAV-insulin).

    ClinicalTrials.gov. PROGRESS: A Phase 1/2 Study of VV-14299 and VV-14300 in Adults With Long-Standing Type 1 Diabetes (NCT07829302). First posted 21 September 2026; updated 5 October 2026; checked 19 October 2026.

  2. [2]
    RELIEVE: A Phase 1/2 Study of VV-14300 in Adults With Long-Standing Type 1 Diabetes (NCT07831798) · Trial registry · 2026-10-05 — Checked 19 October 2026 (first posted 21 September 2026, updated 5 October 2026). Recruiting in Canada and New Zealand; estimated n=29; adults 18–65 with T1D >=5 years on AID; tests ultrasound-guided intramuscular VV-14300 (AAV-glucokinase) monotherapy.

    ClinicalTrials.gov. RELIEVE: A Phase 1/2 Study of VV-14300 in Adults With Long-Standing Type 1 Diabetes (NCT07831798). First posted 21 September 2026; updated 5 October 2026; checked 19 October 2026.

  3. [3]
    KRIYA.288 Type 1 Diabetes — current programme specifications · Manufacturer — Reviewed 19 October 2026. Lists glucokinase payload, intramuscular outpatient administration and sponsor-designated Phase 1/2.

    Kriya Therapeutics. KRIYA.288 Type 1 Diabetes, reviewed 19 October 2026.

  4. [4]
    Gene Therapy to Be Studied for Treating Type 1 Diabetes (KRIYA-839) · Science journalism — Historical media description; now superseded for protocol details by NCT07829302 and NCT07831798.

    Medscape. Gene Therapy to Be Studied for Treating Type 1 Diabetes.

  5. [5]
    Treatment of diabetes and long-term survival after insulin and glucokinase gene therapy · Peer-reviewed study · 2013-05-01 — Historical animal combination-gene-therapy evidence, not human VV-14299/VV-14300 results.

    Callejas D, et al. Treatment of diabetes and long-term survival after insulin and glucokinase gene therapy. Diabetes (2013).