Fractyl Health has received approval to conduct a Phase I/II human study of the gene therapy RJVA-001 in Europe (Netherlands) and plans to initiate the study in Australia as well.

• This gene therapy is a one-time, beta-cell–targeted treatmentdesigned to enable the body to produce GLP-1 in response to meals.

• Study objectives:Assess safety, tolerability, and preliminary effects on glucose control. Patients will be monitored for 12 months and followed for up to 5 years.

• RJVA-001 is the first AAV-based therapy for type 2 diabetesto enter clinical development.

• Fractyl also has other treatments in development:

• Revita:An outpatient endoscopic procedure for weight loss, currently in a pivotal study through 2027.

• RJVA-002:Another gene therapy in preclinical development.

• The use of GLP-1RA drugs for weight loss and diabetes management is rapidly expanding, with the GLP-1 pill market expected to grow from $3.2 billion in 2025 to $34.3 billion in 2031.

https://www.clinicaltrialsarena.com/news/fractyl-healths-glp-1-gene-therapy-trial-given-green-light/?cf-view