Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men (OHH)

Mereo BioPharma

Status and phase: Terminated; Phase 2

Conditions: Obese Hypogonadotropic Hypogonadism

Treatments: Drug: Investigational new drug company code: BGS649; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01200862

CBGS649A2204

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

29 participants in 3 patient groups, including a placebo group

BGS649 (Part 1)

Experimental group

Description:

BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.

Treatment:

Drug: Investigational new drug company code: BGS649

Placebo to BGS649 (Part 2)

Placebo Comparator group

Description:

Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).

Treatment:

Drug: Placebo

BGS649 (Part 2)

Experimental group

Description:

0.3 or 0.1mg hard gelatin capsules of BGS649 given orally. 0.3mg on Day 1 and 0.1 on all other treatment visits (week 1 to 11).

Treatment:

Drug: Investigational new drug company code: BGS649