Pharmacodynamic Study of TAK-448 in Men With Hypogonadotropic Hypogonadism

Chief investigator:Rury Holman

Sponsor:Takeda Development Centre Europe Ltd

Funder:Takeda Development Centre Europe Ltd

Reference number: NCT02369796
EudraCT 2014-002155-25

The TAK-448-2001 study evaluated whether treatment with the long-acting kisspeptin analogue TAK-448 could correct low testosterone levels in men with type 2 diabetes.


Open-label, adaptive design assessing serum testosterone responses to varying frequencies and doses of TAK-448 in overweight men with hypogonadotropic hypogonadism.


TAK-448 acutely stimulated serum testosterone secretion in a dose dependent manner, but no regimen could be identified that maintained testosterone secretion within the normal range. The abstract is available here.


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