A study to assess the safety and tolerability of AZP-531
Research type
Research Study
Full title
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZP-531 in Healthy Volunteers, Overweight/Obese Volunteers and Patients with Type 2 Diabetes Mellitus.
IRAS ID
130083
Contact name
James Ritter
Contact email
Sponsor organisation
Alize Pharma
Eudract number
2013-001053-27
Research summary
AZP-531, a stable analogue of unacylated-ghrelin (a peptide hormone secreted by the stomach), is being developed by Alizé Pharma, because it may be useful in the treatment of type 2 diabetes mellitus. This study has three parts: a single ascending dose study in healthy subjects, a multiple dose study in overweight/obese but otherwise healthy subjects and a multiple dose study in patients with type 2 diabetes mellitus. The purpose of the study is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) various increasing single and multiple subcutaneous (just under the skin) doses of AZP-531 in healthy volunteers, overweight/obese volunteers and patients with type 2 diabetes mellitus. This will be the first time AZP-531 has been given to human subjects, and the study has been designed to provide data on which to base future work to establish the safety and efficacy of AZP-531 in treating patients with type 2 diabetes mellitus.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/0737
Date of REC Opinion
4 Jul 2013
REC opinion
Further Information Favourable Opinion