vTv Therapeutics Announces FDA Lifts Clinical Hold on Cadisegliatin Clinical Program for Type 1 Diabetes
High Point, NC, March 17, 2025 – vTv Therapeutics, a clinical-stage biopharmaceutical company, recently announced that the Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial for the treatment of type 1 diabetes (T1D).
What is Cadisegliatin?
Cadisegliatin is a potential first-in-class oral adjunctive therapy being developed by vTv Therapeutics. It is being investigated as an add-on treatment to insulin for individuals with T1D. The drug aims to address the underlying metabolic dysfunction in T1D, which can lead to improved glucose control and potential reduction in the overall insulin dose required.
CATT1 Phase 3 Trial Resumes with Amended Protocol
The CATT1 Phase 3 trial, which was previously placed on clinical hold by the FDA, will resume following the submission and acceptance of a protocol amendment. The primary change in the amendment is a shortening of the overall duration of the trial from 12 to 6 months.
Impact on Individuals with Type 1 Diabetes
For individuals with T1D, the potential approval of cadisegliatin as an oral adjunctive therapy could mean several benefits:
- Improved glucose control:
- Reduced insulin dose requirements
- Improved quality of life
- Reduced risk of hypoglycemia
- Reduced burden of multiple daily injections
Impact on the World
The potential approval of cadisegliatin as an oral adjunctive therapy for T1D could have a significant impact on the diabetes community:
- Improved glucose control for millions of people with T1D
- Reduced healthcare costs associated with insulin therapy
- Reduced burden on healthcare systems
- Improved quality of life for individuals with T1D
- Encouragement of further research and development in the field of T1D treatments
Conclusion
vTv Therapeutics’ announcement of the FDA’s decision to lift the clinical hold on the cadisegliatin clinical program is a significant step forward in the development of a potential first-in-class oral adjunctive therapy for the treatment of type 1 diabetes. The CATT1 Phase 3 trial, which is expected to resume following the submission and acceptance of a protocol amendment, could lead to improved glucose control, reduced insulin dose requirements, and improved quality of life for millions of people with T1D. Furthermore, this development could have a positive impact on the healthcare system and encourage further research and development in the field of T1D treatments.
Stay tuned for further updates on the progress of the CATT1 Phase 3 trial and the potential approval of cadisegliatin as an oral adjunctive therapy for T1D.
