XNAB SAD/MAD Japanese study

• Research type

  Research Study

• Full title

  A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of the Oxyntomodulin Analog, LY2944876, in Healthy Japanese Subjects and Healthy Non-Japanese Subjects

• IRAS ID

  157802

• Sponsor organisation

  Eli Lilly and Company Ltd

• Eudract number

  2014-000075-56

• Research summary

  Oxyntomodulin is a hormone (chemical) produced by the body after meals which promotes satiety (the feeling of being full after a meal) and increases the body's ability to effectively use insulin to control blood sugar levels. LY2944876 is a drug which is similar to oxyntomodulin but has a special molecule added on to the end to stop it being broken down quickly by the body. This drug is being developed as a treatment for obesity (abnormally high body weight) and Type 2 Diabetes which is, in part, due to the body being unable to effectively use insulin.
  Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese subjects as this is a requirement for the future marketing of the study drug in Japan. Part B of the study will investigate the safety and tolerability of multiple doses of LY2944876 in non-Japanese subjects.
  Part A will involve administration of single ascending doses to three treatment groups to investigate the safety, tolerability, study drug levels in the blood and the effect that the drug has on the body in male and female Japanese subjects.
  In Part B, 2 groups of subjects will receive multiple doses over 7 or 12 days to investigate the safety, tolerability, study drug levels in the blood and the effect the drug has on the body after multiple doses.
  All subjects will be aged between 20 to 65 years (Part 1) or 18 and 65 years (Part 2).
  All doses will be administered as injections into the fatty layer just beneath the skin.
  All subjects will attend a post-study safety assessment approximately 6 weeks after their final dose.

  In both parts following review of data from earlier groups, it is intended that the dose level will increase between each group.

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/0140

• Date of REC Opinion

  23 Jun 2014

• REC opinion

  Favourable Opinion