TAK-448-2001, PD TAK448, male type 2 DM, Hypogonadotropic Hypogonadism
Research type
Research Study
Full title
An Open-Label, Phase 2a Study to Evaluate the Pharmacodynamics of Different Dosing Regimens of TAK-448, a Kisspeptin Agonist, in Male Overweight/Obese Type 2 Diabetes Mellitus Subjects With Hypogonadotropic Hypogonadism
IRAS ID
161714
Contact name
Rury Holman
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2014-002155-25
Duration of Study in the UK
1 years, 3 months, 28 days
Research summary
This is a phase 2a open-label, sequential/parallel study, to evaluate the effects on serum testosterone (ST) compared with Baseline after 4 weeks administration of different repeated doses and dosing frequencies of TAK-448 to overweight/obese male patients, aged between 18 and 60, who are clinically diagnosed type 2 diabetes mellitus (T2DM) subjects with hypogonadotropic hypogonadism (HH).
Low testosterone levels in men are associated with increased cardiovascular risk. Men with type 2 diabetes commonly have low testosterone levels – and some studies have shown improvements in cardiovascular risk markers in such men treated with testosterone replacement.
Kisspeptin is a naturally occurring hormone, which is present in the human brain and controls release of testosterone and other reproductive hormones. Animal studies suggest that the levels of this hormone might be low in diseases like type 2 diabetes. Previous studies have shown that administration of man-made kisspeptin can return levels of testosterone to normal in men with type 2 diabetes.
The drug we are testing is called TAK-448 and is a longer acting form of kisspeptin – previous studies suggest that if this investigational medicine is given intermittently even at fairly low doses, reproductive hormones including testosterone can be powerfully stimulated. This study aims to find out how much TAK-448 should be given and how often to give it in order to increase testosterone to a potentially beneficial level.
A maximum of six groups of eight patients will participate in this study, making 48 patients in total. Each group will take part in the study for a maximum of 12 weeks and will receive treatment for 4 weeks.REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/1950
Date of REC Opinion
17 Nov 2014
REC opinion
Favourable Opinion