Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
NCT ID: NCT02730169
Last Updated: 2022-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
271 participants
INTERVENTIONAL
2016-05-12
2018-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BGS649 0.1 mg
BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)
BGS649
Capsules were taken weekly for a maximum of 24 weeks
BGS649 0.3 mg
BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)
BGS649
Capsules were taken weekly for a maximum of 24 weeks
BGS649 1.0 mg
BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)
BGS649
Capsules were taken weekly for a maximum of 24 weeks
Placebo
Placebo weekly (3 indistinguishable placebo capsules)
Placebo
Capsules were taken weekly for a maximum of 24 weeks
Interventions
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BGS649
Capsules were taken weekly for a maximum of 24 weeks
Placebo
Capsules were taken weekly for a maximum of 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* Other types of hypogonadotropic hypogonadism or primary hypogonadism
* Any other pituitary or hypothalamic disease
18 Years
65 Years
MALE
No
Sponsors
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Mereo BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Hugh Jones
Role: PRINCIPAL_INVESTIGATOR
Barnsley Hospital NHS Foundation Trust
Locations
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Mereo Research Site
Birmingham, Alabama, United States
Mereo Research Site
Mobile, Alabama, United States
Mereo Research Site
Chandler, Arizona, United States
Mereo Research Site
Phoenix, Arizona, United States
Mereo Research Site
Scottsdale, Arizona, United States
Mereo Research Site
Anaheim, California, United States
Mereo Research Site
Carlsbad, California, United States
Mereo Research Site
Greenbrae, California, United States
Mereo Research Site
Lincoln, California, United States
Mereo Research Site
Los Angeles, California, United States
Mereo Research Site
San Diego, California, United States
Mereo Research Site
Bradenton, Florida, United States
Mereo Research Site
DeLand, Florida, United States
Mereo Research Site
Fort Myers, Florida, United States
Mereo Research Site
Hialeah, Florida, United States
Mereo Research Site
Homestead, Florida, United States
Mereo Research Site
St. Petersburg, Florida, United States
Mereo Research Site
Meridian, Idaho, United States
Mereo Research Site
Gurnee, Illinois, United States
Mereo Research Site
Evansville, Indiana, United States
Mereo Research Site
New Orleans, Louisiana, United States
Mereo Research Site
Baltimore, Maryland, United States
Mereo Research Site
Elkridge, Maryland, United States
Mereo Research Site
St Louis, Missouri, United States
Mereo Research Site
Omaha, Nebraska, United States
Mereo Research Site
Henderson, Nevada, United States
Mereo Research Site
Las Vegas, Nevada, United States
Mereo Research Site
Albany, New York, United States
Mereo Research Site
Garden City, New York, United States
Mereo Research Site
Great Neck, New York, United States
Mereo Research Site
New York, New York, United States
Mereo Research Site
Rochester, New York, United States
Mereo Research Site
Charlotte, North Carolina, United States
Mereo Research Site
Raleigh, North Carolina, United States
Mereo Research Site
Winston-Salem, North Carolina, United States
Mereo Research Site
Middleburg Heights, Ohio, United States
Mereo Research Site
Mt. Pleasant, South Carolina, United States
Mereo Research Site
Nashville, Tennessee, United States
Mereo Research Site
Smyrna, Tennessee, United States
Mereo Research Site
Spring Hill, Tennessee, United States
Mereo Research Site
Dallas, Texas, United States
Mereo Research Site
Fort Worth, Texas, United States
Mereo Research Site
Pearland, Texas, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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West Jordan, Utah, United States
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Norfolk, Virginia, United States
Mereo Research Site
Kenosha, Wisconsin, United States
Mereo Research Site
Ancona, , Italy
Mereo Research Site
Parma, , Italy
Mereo Research Site
Roma, , Italy
Mereo Research Site
Siena, , Italy
Mereo Research Site
Coslada, , Spain
Mereo Research Site
Girona, , Spain
Mereo Research Site
Madrid, , Spain
Mereo Research Site
Majadahonda, , Spain
Mereo Research Site
Barnsley, , United Kingdom
Mereo Research Site
Coventry, , United Kingdom
Mereo Research Site
Dundee, , United Kingdom
Mereo Research Site
Edinburgh, , United Kingdom
Mereo Research Site
Hull, , United Kingdom
Mereo Research Site
Manchester, , United Kingdom
Mereo Research Site
Newcastle, , United Kingdom
Countries
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References
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Jones TH, Dobs AS, Randeva H, Moore W, Parkin JM. Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial. Eur J Endocrinol. 2023 Sep 1;189(3):297-308. doi: 10.1093/ejendo/lvad099.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MBGS205
Identifier Type: -
Identifier Source: org_study_id
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