PROGRESS: VV-14299 and VV-14300 intramuscular AAV gene therapy in T1D
What this study tests
A first-in-human phase 1/2 adaptive dose-escalation trial evaluating intramuscular AAV gene therapy delivering glucokinase (VV-14300) alone or co-administered with insulin (VV-14299) in adults with long-standing T1D using an insulin pump.
Editorial review: .
Registry checked: 2026-10-19. Registry’s own update: 2026-10-05.
Most recent recorded citation date: 2026-10-05. 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
Evidence at a glance
- Who can enter the study?
- Adults aged 18–65 years with clinical diagnosis of T1D for at least 5 years, BMI 20.0 to under 30.0 kg/m², managed with an automated insulin delivery (AID) system for at least 3 months before screening, with suboptimal glycemic control and C-peptide negativity. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Registry checked 19 October 2026 (ClinicalTrials.gov last update 5 October 2026): recruiting in Melbourne, Australia; estimated n=29; estimated primary and study completion July 2029.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Australia. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Australian sites in the registry
- Kriya Clinical Trial Site, Melbourne — Recruiting
Overall recruitment does not imply availability at every site. Confirm eligibility and local recruitment with the study team.
Primary endpoints
- Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs through 52 weeks
- Change from baseline in CGM blood glucose metrics at 16 weeks
- Change from baseline in HbA1c at 16 weeks
The full picture
What the study asks
PROGRESS is a first-in-human, adaptive, model-based dose-escalation phase 1/2 trial testing ultrasound-guided intramuscular injections of adeno-associated virus (AAV) gene therapy vectors encoding glucokinase (VV-14300) alone or co-administered with insulin (VV-14299) in adults with long-standing type 1 diabetes.1
Who it involves
Adults aged 18–65 years with a clinical diagnosis of type 1 diabetes for at least 5 years, body mass index 20.0 to under 30.0 kg/m², C-peptide negativity, and suboptimal glycemic control despite using an automated insulin delivery (AID) system for at least 3 months prior to screening. Additional safety and exclusion criteria apply.1
Design and timing
The registry lists an estimated enrollment of 29 participants, with a single recruiting site registered in Melbourne, Australia. Estimated study start is October 2026, with estimated primary completion and study completion in July 2029. Co-primary endpoints assess safety through 52 weeks alongside changes from baseline in CGM blood glucose metrics and HbA1c at 16 weeks.1
Evidence and limits
No results are posted. First-in-human registration and open recruitment establish that clinical testing has begun, not that intramuscular AAV insulin/glucokinase gene therapy is safe or effective in humans.1
Sources
- [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 — Protocol and current registry status checked 19 October 2026: RECRUITING in Melbourne, Australia; estimated n=29; last update posted 5 October 2026; no results posted.
ClinicalTrials.gov. NCT07829302. Record checked 19 October 2026; first posted 2026-09-21; last update posted 2026-10-05.