Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

Summary

The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.

Timeline

Start

2016-05-12

Primary completion

2018-02-15

Completion

2018-05-19

Outcome

Met primary endpoint

paper The primary endpoint was achieved in all leflutrozole-treated groups by 24 weeks with a dose-tiered response PMID 37579053 ↗

Publications

• Jones TH, Dobs AS, Randeva H, Moore W, Parkin JM. Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial. Eur J Endocrinol. 2023 Sep 1;189(3):297-308. doi: 10.1093/ejendo/lvad099.

Drugs

Indications