Status:
TERMINATED
Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men
Lead Sponsor:
Mereo BioPharma
Collaborating Sponsors:
Novartis
Conditions:
Obese Hypogonadotropic Hypogonadism
Eligibility:
MALE
30-65 years
Phase:
PHASE2
Brief Summary
This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. ...
Eligibility Criteria
Inclusion
- Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:
- Patients with a Body Mass Index (BMI) ≥ 30 kg/m2
- Patients with a morning serum total testosterone level \< 300 ng/dL on at least two separate occasions during the Screening and/or Baseline periods.
- Patients with inappropriately low gonadotropins at screening given the low testosterone:
- Luteinizing hormone (LH) ≤ ULN
- Follicle stimulating hormone (FSH) ≤ ULN
- Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)
- Normal hypothalamic/pituitary function, including:
- Prolactin: within the normal range
- Thyroid stimulating hormone (TSH): within the normal range
- Ferritin: within the normal range
- Patients agree to use a barrier method of contraception (e.g., condom), for the duration of the study and for at least 3 months following their Study Completion visit to prevent BGS649 exposure to their partners.
Exclusion
- Patients with hypogonadism, not related to obesity or as a result of other underlying issues
- Patients with significant major organ class illness (e.g. kidney or liver disease).
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01200862
Start Date
August 1 2010
End Date
August 1 2012
Last Update
October 8 2020
Active Locations (5)
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1
Novartis Investigative Site
Tucson, Arizona, United States, 85712
2
Novartis Investigative Site
San Diego, California, United States, 92120
3
Novartis Investigative Site
Miramar, Florida, United States, 33025
4
Novartis Investigative Site
West Valley City, Utah, United States, 84120