The RJVA-001 First in Human Trial in Adults with Inadequately Controlled Type 2 Diabetes.

Trial details

Who runs it

Fractyl Health Inc.

Trial code

EU 2025-524438-24-00

Record updated

2026. október 19.

Original description

To evaluate the safety and tolerability of RJVA-001.Read full original descriptionShow less

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.

To evaluate the safety and tolerability of RJVA-001.

Inclusion: 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; Diagnosis of Type 2 Diabetes; Body mass index as indicated in the study protocol; Fasting plasma glucose and hemoglobin A1c levels as stated in the study protocol; Participants are taking glucagon-like peptide-1 receptor agonists (GLP-1RA) at the maximum tolerated maintenance dose and taking permitted non-insulin glucose lowering agents other than GLP-1RA; Random C-peptide level as stated in the study protocol; Normal thyroid function as defined in the study protocol.

Exclusion: 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; Contraindication to systemic steroids or sirolimus; Participant is on a weight loss program and is not in the weight maintenance phase, or is on a GLP-1 weight loss medication; History of non-adherence to diabetes treatment in the previous 6 months, as determined by the Investigator; Concomitant Medication Exclusions as stated in the study protocol; Immunization with live vaccines within 30 days prior to screening, Visit 1; 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; Participant has poorly controlled hypertension as defined in the study protocol; Any other clinical or mental condition which, in the opinion of the Investigator, would jeopardize participant’s safety or makes participant a poor candidate for clinical trial participation; Known history of diabetic retinopathy; Active systemic infection or undergoing treatment for recent infection. Does not apply to completely treated infection; Condition(s) requiring systemic immunomodulation or whose immune status makes the participant a poor candidate for clinical trial participation; History of chronic or acute pancreatitis, or elevated fasting triglycerides as stated in the study protocol; Family history of hemochromatosis or cystic fibrosis, as self-reported by the participants will be documented; History of tuberculosis; Known hypersensitivity or allergy to eggs, milk, wheat, or [13C]-labeled Spirulina substrates; History of hepatic decompensation/acute liver disease, acute or chronic active hepatitis B or C, alcoholic or autoimmune chronic hepatitis as stated in the study protocol. Known portal hypertension; Laboratory and Radiographic Exclusions as stated in the study protocol; History of symptomatic heart failure with reduced or preserved ejection fraction; General contraindications to deep or conscious sedation or general anesthesia or high risk as determined by anesthesiologist; Contraindications to upper gastrointestinal (GI) endoscopy; Symptomatic cholelithiasis or cholecystitis unless treated by cholecystectomy; Any contraindications to the infusate to be delivered.

EU CTIS 2025-524438-24-00