Trials / Completed
CompletedNCT02730169
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 271 (actual)
- Sponsor
- Mereo BioPharma · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGS649 | Capsules were taken weekly for a maximum of 24 weeks |
| DRUG | Placebo | Capsules were taken weekly for a maximum of 24 weeks |
Timeline
- Start date
- 2016-05-12
- Primary completion
- 2018-02-15
- Completion
- 2018-05-19
- First posted
- 2016-04-06
- Last updated
- 2022-09-14
- Results posted
- 2020-11-25
Locations
63 sites across 4 countries: United States, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02730169. Inclusion in this directory is not an endorsement.