Authorised Phase I and Phase II (Integrated)- First administration to humans Type 2 Diabetes

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

EU CTIS ID: 2025-524438-24-00

What this study is testing

To evaluate the safety and tolerability of RJVA-001.

Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation.
10. Normal calcitonin level as stated in the study protocol.
11. Based on Investigator’s judgement, continuous dose escalation or modification of participant’s current treatment regimen is deemed unacceptable.
12. Participant has deferred insulin therapy.
13. 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.
14. Participants must be willing to abstain from semen/blood donation through 1 year after RJVA-001 injection.

You likely can't join if

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.
18. History of clinically significant valvular heart disease or severe aortic stenosis.
19. Acute coronary syndrome, stroke or transient ischemic attack as stated in the study protocol.
2. History of dose-limiting persistent adverse side effects from GLP-1RA use.
20. History of severe peripheral vascular disease.
21. 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.

See the full eligibility criteria

Who can join

1. Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation.
10. Normal calcitonin level as stated in the study protocol.
11. Based on Investigator’s judgement, continuous dose escalation or modification of participant’s current treatment regimen is deemed unacceptable.
12. Participant has deferred insulin therapy.
13. 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.
14. Participants must be willing to abstain from semen/blood donation through 1 year after RJVA-001 injection.
15. Participants must be willing to abstain from alcohol use until completion of the sirolimus taper.
16. Participants must agree not to initiate any new or intensive diet or exercise regimens and/or any new weight loss medications during study participation.
2. Age 35 to 70 years (inclusive).
3. Agree to use appropriate form of contaception for the study duration and for at least 1 year after RJVA-001 infusion.
4. Diagnosis of Type 2 Diabetes.
5. Body mass index as indicated in the study protocol.
6. Fasting plasma glucose and hemoglobin A1c levels as stated in the study protocol.
7. 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.
8. Random C-peptide level as stated in the study protocol.
9. Normal thyroid function as defined in the study protocol.

What rules you out

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.
18. History of clinically significant valvular heart disease or severe aortic stenosis.
19. Acute coronary syndrome, stroke or transient ischemic attack as stated in the study protocol.
2. History of dose-limiting persistent adverse side effects from GLP-1RA use.
20. History of severe peripheral vascular disease.
21. 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.
22. Suspected GI malignancy.
23. History of blood dyscrasias or any disorders causing hemolysis or unstable erythrocytes.
24. History of alcohol or illicit substance abuse as stated in the study protocol.
25. 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.
26. Contraindication to systemic steroids or sirolimus.
10. General contraindications to deep or conscious sedation or general anesthesia or high risk as determined by anesthesiologist.
27. Participant is on a weight loss program and is not in the weight maintenance phase, or is on a GLP-1 weight loss medication.
28. Participant has poorly controlled hypertension as defined in the study protocol.
29. 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.
3. History of non-adherence to diabetes treatment in the previous 6 months, as determined by the Investigator.
30. Laboratory and Radiographic Exclusions as stated in the study protocol.
4. Known history of diabetic retinopathy.
5. Active systemic infection or undergoing treatment for recent infection. Does not apply to completely treated infection.
6. Condition(s) requiring systemic immunomodulation or whose immune status makes the participant a poor candidate for clinical trial participation.
7. History of chronic or acute pancreatitis, or elevated fasting triglycerides as stated in the study protocol.
8. Family history of hemochromatosis or cystic fibrosis, as self-reported by the participants will be documented.
11. Contraindications to upper gastrointestinal (GI) endoscopy.
9. Symptomatic cholelithiasis or cholecystitis unless treated by cholecystectomy.
31. Concomitant Medication Exclusions as stated in the study protocol.
12. History of tuberculosis.
13. Immunization with live vaccines within 30 days prior to screening, Visit 1.
14. Known hypersensitivity or allergy to eggs, milk, wheat, or [13C]-labeled Spirulina substrates.
15. Any contraindications to the infusate to be delivered.
16. 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.
17. History of symptomatic heart failure with reduced or preserved ejection fraction.

The study team makes the final eligibility decision.

Where it's taking place

Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Australia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease Atrial fibrillation

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.