FDA Lifts Clinical Hold on vTv Therapeutics' Cadisegliatin for Type 1 Diabetes
• FDA has lifted the clinical hold on vTv Therapeutics' cadisegliatin program, allowing the CATT1 Phase 3 trial for type 1 diabetes to resume after addressing concerns about a chromatographic signal.
• The company plans to amend the protocol to shorten the trial duration from 12 to 6 months, expediting topline data collection while maintaining the original primary endpoint of measuring hypoglycemia rates.
• Cadisegliatin, a liver-selective glucokinase activator, has potential to become the first oral adjunctive therapy to insulin for type 1 diabetes, having been well-tolerated in over 500 subjects to date.
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