Clinical Trial Details


Research Study Summary

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


The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotrophic 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.

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CW ID: 224835
Date Last Changed: June 12, 2017

Clinical Trial Snapshot

Both Male and Female
18 to 65 Years
Overall Status
Facility Type


Inclusion Criteria:
  • Adult male subject aged 18 to 65 years inclusive
  • BMI > 30 kg/m2 and ≤ kg/m2
  • Serum total testosterone concentration below the normal range
  • LH levels below the upper limit of normal
  • Oestradiol levels within or above the normal range of approved assay
  • At least two symptoms of androgen deficiency present for at least 2 months prior to the
  • first Screening Visit, with at least one of these being a sexual dysfunction
Exclusion Criteria:
  • Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
  • Other types of hypogonadotrophic hypogonadism or primary hypogonadism
  • Any other pituitary or hypothalamic disease


Coastal Carolina Research Center
1156 Bowman Road, Suite 102
Mount Pleasant, SC 29464
Phone: 843-856-3784
Fax: 843-856-3788

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Research Center Information:

Coastal Carolina Research Center

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