Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

An Open-label Dose Finding Study Followed by a Parallel Group, Randomized, Double-blind Study to Evaluate the Safety, Tolerability and Pharmacodynamics of 12 Week BGS649 Treatment in Obese, Hypogonadotropic Hypogonadal Men

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

Inclusion Criteria:

• 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 Criteria:

• 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