Clinical trial NCT01200862: Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obese Hypogonadotropic Hypogonadism
Keywords: Obese
obesity
hypogonadism
hypogonadotropic
hyperestrogenemic
testosterone
hypogonadal
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2010-09-14
Enrollment: 29
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Achieving Normal Testosterone Levels
timeFrame: At Week 4 and 12
measure: Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12
timeFrame: Baseline, Week 4 and Week 12
Secondary outcomes:
measure: Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)
timeFrame: 11 weeks
measure: Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)
timeFrame: Week 1 to Week 11
measure: Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)
timeFrame: Week 1 to Week 11
measure: PK of BGS649 Elimination Half-life Associated With the Terminal Slope of a Semi Logarithmic Concentration-time Curve (T1/2)
timeFrame: Week 1 to Week 11
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Miramar
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Valley City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
Study officials:
affiliation: Mereo BioPharma
name: Jacqueline Parkin, PhD FRCP
role: STUDY_DIRECTOR
References: