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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

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Trial Profile

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 May 2024

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At a glance

  • Drugs DD 01 (Primary)
  • Indications Non-alcoholic fatty liver disease; Obesity; Type 2 diabetes mellitus
  • Focus Adverse reactions; First in man
  • Sponsors Neuraly

    • Most Recent Events

    • 02 Apr 2024 According to D&D Pharmatech media release, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of DD01 for the treatment of adults with non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH) based on the data from this trial.
    • 26 Jun 2023 Status changed to completed, according to Results presented at the 83rd Annual Scientific Sessions of the American Diabetes Association
    • 26 Jun 2023 Results presented at the 83rd Annual Scientific Sessions of the American Diabetes Association

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