A Phase IIb Multicentre, Double-Blind, Dose-Ranging, Randomised, Placebo-Controlled Study Evaluating Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male subject aged 18 to 65 years inclusive
- •BMI > 30 kg/m2 and < 50 kg/m2
- •Serum total testosterone concentration below the normal range
- •LH levels below the upper limit of normal
- •Oestradiol levels within or above the normal range of approved assay
- •At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction
排除标准
- •Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
- •Other types of hypogonadotropic hypogonadism or primary hypogonadism
- •Any other pituitary or hypothalamic disease
研究组 & 干预措施
BGS649 0.1 mg
BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)
干预措施: BGS649 (Drug)
BGS649 0.3 mg
BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)
干预措施: BGS649 (Drug)
BGS649 1.0 mg
BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)
干预措施: BGS649 (Drug)
Placebo
Placebo weekly (3 indistinguishable placebo capsules)
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
时间窗: 24 weeks of treatment
Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.
次要结局
- The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24(Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks)
- Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24(Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks)
- Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.(24 weeks of treatment)
- Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.(Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks)
- Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.(Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks)
- Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.(Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment)
- Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.(Week 24 and week 24/End of treatment)