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
We found this trial at
49
sites
Fort Myers, Florida
924
mi
from 43215
Fort Myers, FL
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Albany, New York
515
mi
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Albany, NY
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Anaheim, California
1960
mi
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Anaheim, CA
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4675
mi
from 43215
Ancona,
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Baltimore, Maryland
344
mi
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Baltimore, MD
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Birmingham, Alabama
491
mi
from 43215
Birmingham, AL
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Bradenton, Florida
861
mi
from 43215
Bradenton, FL
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Carlsbad, California
1949
mi
from 43215
Carlsbad, CA
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Chandler, Arizona
1654
mi
from 43215
Chandler, AZ
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Charlotte, North Carolina
348
mi
from 43215
Charlotte, NC
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Dallas, Texas
911
mi
from 43215
Dallas, TX
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Deland, Florida
761
mi
from 43215
Deland, FL
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Elkridge, Maryland
339
mi
from 43215
Elkridge, MD
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Evansville, Indiana
280
mi
from 43215
Evansville, IN
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Fort Worth, Texas
938
mi
from 43215
Fort Worth, TX
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Garden City, New York
496
mi
from 43215
Garden City, NY
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Great Neck, New York
492
mi
from 43215
Great Neck, NY
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Greenbrae, California
2109
mi
from 43215
Greenbrae, CA
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Gurnee, Illinois
303
mi
from 43215
Gurnee, IL
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Henderson, Nevada
1751
mi
from 43215
Henderson, NV
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Hialeah, Florida
987
mi
from 43215
Hialeah, FL
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Homestead, Florida
1012
mi
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Homestead, FL
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Kenosha, Wisconsin
307
mi
from 43215
Kenosha, WI
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Las Vegas, Nevada
1756
mi
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Las Vegas, NV
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Lincoln, California
2027
mi
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Lincoln, CA
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Los Angeles, California
1972
mi
from 43215
Los Angeles, CA
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Meridian, Idaho
1725
mi
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Meridian, ID
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Middleburg Heights, Ohio
115
mi
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Middleburg Heights, OH
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Mobile, Alabama
699
mi
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Mobile, AL
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1156 Bowman Road
Mount Pleasant, South Carolina 29464
524
mi
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Mount Pleasant, SC
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Murray, Utah
1514
mi
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Murray, UT
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Nashville, Tennessee
332
mi
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Nashville, TN
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New Orleans, Louisiana
798
mi
from 43215
New Orleans, LA
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New York, New York
442
mi
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New York, NY
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Norfolk, Virginia
423
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Norfolk, VA
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Omaha, Nebraska
682
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Omaha, NE
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Pearland, Texas
998
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Pearland, TX
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Phoenix, Arizona
1662
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Phoenix, AZ
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Raleigh, North Carolina
375
mi
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Raleigh, NC
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Rochester, New York
355
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Rochester, NY
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1210 South Vandeventer Avenue
Saint Louis, Missouri 63110
397
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Saint Louis, MO
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Saint Petersburg, Florida
842
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Saint Petersburg, FL
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San Antonio, Texas
1138
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San Antonio, TX
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San Diego, California
1951
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San Diego, CA
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Scottsdale, Arizona
1651
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Scottsdale, AZ
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Smyrna, Tennessee
400
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Smyrna, TN
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Spring Hill, Tennessee
279
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Spring Hill, TN
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West Jordan, Utah
1517
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West Jordan, UT
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Winston-Salem, North Carolina
306
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from 43215
Winston-Salem, NC
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