NCT01200862

Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

An Open-label Dose Finding Study Followed by a Parallel Group, Randomized, Double-blind Study to Evaluate the Safety, Tolerability and Pharmacodynamics of 12 Week BGS649 Treatment in Obese, Hypogonadotropic Hypogonadal Men

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men

Conditions

• Obese Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	Investigational new drug company code: BGS649
DRUG	Placebo

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-09-14
• Last updated: 2020-10-08
• Results posted: 2020-10-08

Locations

5 sites across 2 countries: United States, Canada