Administration of multiple ascending doses of AZD2820 to obese men
Research type
Research Study
Full title
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 after Administration of Multiple Ascending Doses
IRAS ID
90035
Contact name
James Ritter
Sponsor organisation
AstraZeneca
Eudract number
2011-003242-41
Research summary
AZD2820 works in the brain to suppress appetite. It weakly activates a substance in the part of the brain that controls feeding called the MC4 receptor. This recognises and responds to a chemical messenger in the brain that controls appetite and how ??full? we feel. AZD2820 is given by subcutaneous (under the skin) injection and is being developed as an anti-obesity drug. Another drug (BMT), that activates MC4 receptors more strongly, is in clinical development for treatment of erectile dysfunction. It has previously been administered to obese humans and caused weight loss. In an ongoing study we are investigating the tolerability of single doses of AZD2820 in healthy men, and so far this drug has been safe and well tolerated. This present study is designed to find out if repeated doses of AZD2820 administered subcutaneously once daily are well tolerated, how obese but otherwise healthy people handle (i.e. absorb, break down and excrete) this drug, and if it affects the amount of food they eat. Up to 72 obese but otherwise healthy men will be studied in groups of 9. After screening, subjects will be admitted to a residential drug research unit for a 15 day dosing period during which they will be carefully monitored. The final outpatient visit is 29 days after the final dose. The results from this study will help plan the further development of AZD2820.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
11/IE/0160
Date of REC Opinion
19 Dec 2011
REC opinion
Further Information Favourable Opinion