2025-524438-24-00
Recruiting
Phase 2
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.
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Fractyl Health Inc.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
Overview
Brief Summary
To evaluate the safety and tolerability of RJVA-001.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation.
- •Normal calcitonin level as stated in the study protocol.
- •Based on Investigator’s judgement, continuous dose escalation or modification of participant’s current treatment regimen is deemed unacceptable.
- •Participant has deferred insulin therapy.
- •Able to tolerate a once-weekly injectable, once-daily injectable or oral GLP-1RA treatment as evidenced by ongoing treatment and benefit from GLP-1RAs at an efficacious dose.
- •Participants must be willing to abstain from semen/blood donation through 1 year after RJVA-001 injection.
- •Participants must be willing to abstain from alcohol use until completion of the sirolimus taper.
- •Participants must agree not to initiate any new or intensive diet or exercise regimens and/or any new weight loss medications during study participation.
- •Age 35 to 70 years (inclusive).
- •Agree to use appropriate form of contaception for the study duration and for at least 1 year after RJVA-001 infusion.
Exclusion Criteria
- •Diagnosis of Type 1 diabetes or history of ketoacidosis, monogenic diabetes or latent autoimmune diabetes of adults or presence of 1 or more islet cell autoantibodies.
- •History of clinically significant valvular heart disease or severe aortic stenosis.
- •Acute coronary syndrome, stroke or transient ischemic attack as stated in the study protocol.
- •History of dose-limiting persistent adverse side effects from GLP-1RA use.
- •History of severe peripheral vascular disease.
- •History of active malignancy or partial remission from clinically significant malignancy, personal or familial history of medullary thyroid carcinoma as stated in the study protocol.
- •Suspected GI malignancy.
- •History of blood dyscrasias or any disorders causing hemolysis or unstable erythrocytes.
- •History of alcohol or illicit substance abuse as stated in the study protocol.
- •Intake of an investigational drug within 5 half-lives prior to visit 1 or active participation in another clinical trial of an investigational drug or device.
Arms & Interventions
RJVA-001
Test
Intervention: RJVA-001 (Drug)
Outcomes
Primary Outcomes
Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
Secondary Outcomes
- 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.
Investigators
Fractyl Health
Scientific
Fractyl Health Inc.
Study Sites (1)
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