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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypogonadotropic Hypogonadism

In brief

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.

Key facts

Study ID

NCT02730169

Run by

Mereo BioPharma

People needed

271

Starts

2016-05-12

Expected to finish

2018-05-19

Last updated by the study team

2022-09-14

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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