Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Obese Hypogonadotropic Hypogonadism

In brief

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. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men

Key facts

Study ID

NCT01200862

Run by

Mereo BioPharma

People needed

29

Starts

2010-08-01

Expected to finish

2012-08-01

Last updated by the study team

2020-10-08

Who can join

Age: 30 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Miramar, Florida, United States
• Novartis Investigative Site — West Valley City, Utah, United States
• Novartis Investigative Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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