RELIEVE: 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 VV-14300 (AAV-mediated glucokinase gene therapy) in adults with long-standing T1D using an automated insulin delivery system.
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 T1D for at least 5 years, BMI 20.0 to under 30.0 kg/m², currently using an automated insulin delivery (AID) system with suboptimal glycemic control. 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 Canada and New Zealand; estimated n=29; estimated primary and study completion November 2028.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: Canada, Other regions. 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.
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 8 weeks
- Change from baseline in HbA1c at 16 weeks
The full picture
What the study asks
RELIEVE is a first-in-human, adaptive, model-based dose-escalation phase 1/2 study evaluating ultrasound-guided intramuscular injections of VV-14300 (an adeno-associated virus vector expressing glucokinase) in adults with long-standing type 1 diabetes using an automated insulin delivery system.1
Who it involves
Adults aged 18–65 years with type 1 diabetes for at least 5 years, body mass index 20.0 to under 30.0 kg/m², and suboptimal glycemic control while using an automated insulin delivery (AID) system. Full eligibility and exclusion criteria are listed in the registry.1
Design and timing
The registry lists an estimated enrollment of 29 participants across sites in Canada and New Zealand. Estimated start is October 2026, with estimated primary completion and overall study completion in November 2028. Primary outcome measures include safety through 52 weeks, CGM metrics at 8 weeks, and HbA1c change at 16 weeks.1
Evidence and limits
No results are posted. This trial tests VV-14300 glucokinase monotherapy alongside background AID insulin therapy and does not establish clinical benefit or insulin independence.1
Sources
- [1]RELIEVE: A Phase 1/2 Study of VV-14300 in Adults With Long-Standing Type 1 Diabetes (NCT07831798) · Trial registry · 2026-10-05 — Protocol and current registry status checked 19 October 2026: RECRUITING in Canada and New Zealand; estimated n=29; last update posted 5 October 2026; no results posted.
ClinicalTrials.gov. NCT07831798. Record checked 19 October 2026; first posted 2026-09-21; last update posted 2026-10-05.