At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 271 enrolled
Drug / intervention
BGS649 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIb Multicentre, Double-Blind, Dose-Ranging, Randomised, Placebo-Controlled Study Evaluating Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
In Brief
A Phase 2 clinical trial evaluating BGS649 and Placebo for Hypogonadotropic Hypogonadism. Completed, enrolled 271 participants across 63 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadotropic Hypogonadism
CountriesItaly, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionFeb 2018
Study CompletionMay 2018
TodayJul 2026
First PostedApr 6, 2016
Enrollment StartMay 12, 2016
Primary CompletionFeb 15, 2018
Study CompletionMay 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.2 years ago
Interventions
BGS649drug
Capsules were taken weekly for a maximum of 24 weeks
Placebodrug
Capsules were taken weekly for a maximum of 24 weeks