MEDI0382, a GLP‐1/glucagon receptor dual agonist, meets safety and tolerability endpoints in a single‐dose, healthy‐subject, randomized, Phase 1 study

Jun 22, 2018British journal of clinical pharmacology

Safety and tolerability of MEDI0382, a drug activating both GLP-1 and glucagon receptors, in a single dose given to healthy volunteers

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Abstract

A total of 36 subjects received MEDI0382, with treatment-emergent adverse events occurring more frequently at doses ≥150 μg.

  • Adverse events related to MEDI0382 were mostly mild or moderate in severity.
  • The most common adverse events included vomiting, nausea, and dizziness.
  • A dose-dependent increase in heart rate was observed with MEDI0382 treatment.
  • MEDI0382 demonstrated a linear pharmacokinetic profile, with a time to maximum plasma concentration ranging from 4.50 to 9.00 hours.
  • The elimination half-life of MEDI0382 was between 9.54 and 12.07 hours.
  • No immunogenicity was detected during the study.

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