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.
Phase 2 – studying effectiveness and dosage
Conditions:
Type 2 Diabetes
Sponsor: Fractyl Health Inc.
trial.available_in:
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Overview
Trial status: Authorised
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.
Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
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.
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 15 participants
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