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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Open-label in Part 1 and double-blind in Part 2.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo to BGS649 (Part 2)
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).
干预措施: Placebo (Drug)
结局指标
主要结局
Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12
时间窗: Baseline, Week 4 and Week 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.
Percentage of Patients Achieving Normal Testosterone Levels
时间窗: At Week 4 and 12
Percentage of patients achieving normal testosterone (2.50 - 9.50 ng/mL) levels at Week 4 and Week 12
次要结局
- Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)(Week 1 to Week 11)
- PK of BGS649 Elimination Half-life Associated With the Terminal Slope of a Semi Logarithmic Concentration-time Curve (T1/2)(Week 1 to Week 11)
- Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)(11 weeks)
- Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)(Week 1 to Week 11)