NCT02908074

A 6 Month Safety Extension Study of MBGS205

A 6 Month, Double-blind Safety Extension Study of MBGS205

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)

Detailed description

This is a 6 months, active treatment, extension study, open to subjects who have completed full 24 weeks in Study MBGS205 (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 \[HH\]).The main purpose of Study MBGS206 is to evaluate long term safety and efficacy parameters in subjects after 12 months exposure with BGS649.

Conditions

• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	BGS649	Capsules will be taken weekly for a maximum of 24 weeks

Timeline

• Start date: 2016-11-15
• Primary completion: 2018-09-08
• Completion: 2018-11-21
• First posted: 2016-09-20
• Last updated: 2023-05-18
• Results posted: 2023-05-18

Locations

37 sites across 1 country: United States