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.

Design

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

Results

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.