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



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:10/6/2018
Start Date:May 12, 2016
End Date:May 19, 2018

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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

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.


Inclusion Criteria:

- Adult male subject aged 18 to 65 years inclusive

- BMI > 30 kg/m2 and < 50 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 hypogonadotropic hypogonadism or primary hypogonadism

- Any other pituitary or hypothalamic disease
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49
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Fort Worth, Texas
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Albany, New York
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Charlotte, North Carolina
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Dallas, Texas
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Middleburg Heights, Ohio
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Mobile, Alabama
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1156 Bowman Road
Mount Pleasant, South Carolina 29464
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Murray, Utah
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1210 South Vandeventer Avenue
Saint Louis, Missouri 63110
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