A Phase 1/2 Open-Label, Single Ascending Dose, First-In-Human Study to Assess Safety and Tolerability of Endoscopic Ultrasound-Guided Pancreatic Infusion of RJVA-001 in Adults With Inadequately Controlled Type 2 Diabetes on Multiple Glucose-Lowering Agents.

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524438-24-00

Enrollment

Registered

2026-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.

Detailed description

1. Change in transgene secretion and glycemic parameters., 2. Anti-AAV9 antibody titers, anti-GLP-1 antibody titers and enzyme-linked immunosorbent spot for AAV9 and GLP-1., 3. Digital polymerase chain reaction for AAV9 in samples., 4. Change from Baseline parameters using continuous glucose monitoring.

Interventions

DRUGRJVA-001

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.	—

Secondary

Measure	Time frame
1. Change in transgene secretion and glycemic parameters., 2. Anti-AAV9 antibody titers, anti-GLP-1 antibody titers and enzyme-linked immunosorbent spot for AAV9 and GLP-1., 3. Digital polymerase chain reaction for AAV9 in samples., 4. Change from Baseline parameters using continuous glucose monitoring.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 24, 2026