Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

Phase 2TerminatedNCT01200862

Mereo BioPharma29 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obese Hypogonadotropic Hypogonadism

Interventions

Investigational new drug company code: BGS649DRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Percentage of Patients Achieving Normal Testosterone Levels

Percentage of patients achieving normal testosterone (2.50 - 9.50 ng/mL) levels at Week 4 and Week 12

Time frame: At Week 4 and 12

Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12

Pharmacodynamic change from baseline in HOMA-IR. Score at week 4 and week 12 as an assessment of insulin resistance. Low score representing high insulin sensitivity and a high score representing low insulin sensitivity or insulin resistance. HOMA-IR is a ration of Fasting insulin (mIU/L) : Fasting glucose (mmol). Pharmacodynamic change in QUICKI score at week 4 and week 12 as an assessment of insulin resistance. The QUICKI scale is a log score and a high score representing high insulin sensitivity and low score indicating low insulin sensitivity. Patients with a score below 0.3 are considered diabetic. Week 12 data is missing because there were inaccuracies in dosing of patients and so the study was terminated, only safety data was collected.

Time frame: Baseline, Week 4 and Week 12

Secondary Outcomes

Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)

PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11. The AUC 0-168 measures the amount of drug within the subjects blood over the 168h post-dosing at these timepoints.

Time frame: 11 weeks

Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)

PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11.

Time frame: Week 1 to Week 11

Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)

Data from ClinicalTrials.gov

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