A study of Y242 in healthy adult men

• Research type

  Research Study

• Full title

  A randomised, placebo controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y242 in adult subjects

• IRAS ID

  86929

• Contact name

  james ritter

• Sponsor organisation

  Imperial College London

• Eudract number

  2011-003549-17

• ISRCTN Number

  xx

• Research summary

  Obesity causes 600 premature deaths per week in the UK and existing treatments are unsatisfactory. A hormone called peptide YY (PYY) reduces food intake but its effects only last for a few hours and it can cause nausea. Y242 is a long-acting variant of PYY which has been developed as a treatment for obesity. Injected under the skin (subcutaneously) in rodents, it acts for more than 72 hours and was not harmful at doses that caused weight loss. With MRC funding, Y242 has passed Good Laboratory Practice toxicology testing and this proposal is for a first in human study in overweight but otherwise healthy men. The study is in two parts, part A (single increasing doses) and part B (repeated increasing doses). The main object is to investigate the safety of Y242 and find out how well it is tolerated. We will also investigate how the body handles Y242 by measuring its concentration in blood sampled at intervals after dosing and will look for any effects on appetite and food consumption. For part A up to 48 subjects are planned, with up to 40 subjects for part B. In each part subjects are divided into groups, each of which is dosed with the same level, starting with a single dose (part A) much lower than is expected to cause an effect. Subjects are admitted to a dedicated Drug Research Unit so they can be closely observed, and are allocated at random (like tossing a coin) to receive Y242 or placebo (dummy). Safety, tolerability and drug concentration data will be summarised and available results considered when considering whether to increase the dose and by how much between groups of subjects.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/1477

• Date of REC Opinion

  21 Nov 2011

• REC opinion

  Further Information Favourable Opinion