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Phase 1/2Recruiting

VV-14299 and VV-14300 for the Treatment of Type 1 Diabetes (PROGRESS)

A Phase 1/2, First-in-Human, Adaptive, Model-based, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of VV-14299 and VV-14300 (Adeno-associated Virus Vector-mediated Insulin and Glucokinase) in Adults With Long-Standing Type 1 Diabetes and Suboptimal Glycemic Control Using a Continuous Subcutaneous Insulin Infusion (CSII) Pump

Sponsor
Kriya Therapeutics, Inc. (Industry)
Enrolment
29 planned
Conditions
Type 1 Diabetes Mellitus
Interventions
VV-14300; VV-14299
Ages
adults, older adults
Registry
NCT07829302

Full record on ClinicalTrials.gov

From the registry

This study is testing VV-14299 and VV-14300 or VV-14300 alone in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system. VV-14299 and VV-14300 are investigational gene therapies that are injected into muscle and are designed to work together to help remove excess sugar from the blood.

Primary outcomes

  • Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs
  • Change from Baseline in blood glucose as measured by continuous glucose monitoring (CGM)
  • Change from Baseline in blood glucose as measured by hemoglobin A1c (HBA1c) level
  • Change from Baseline in blood glucose as measured by fructosamine level

History

  1. Primary completion expected

  2. Started

  3. Last registry update

  4. Registered