Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
- Registration Number
- NCT02730169
- Lead Sponsor
- Mereo BioPharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 271
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BGS649 0.1 mg BGS649 BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649 0.3 mg BGS649 BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649 1.0 mg BGS649 BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) Placebo Placebo Placebo weekly (3 indistinguishable placebo capsules)
- Primary Outcome Measures
Name Time Method Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment 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.
- Secondary Outcome Measures
Name Time Method 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 Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \>1000 ng/dL were considered super-physiological outside the normal range.
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 Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.
Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. 24 weeks of treatment Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \>1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.
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 LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
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 FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
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 Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. Week 24 and week 24/End of treatment Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.
Trial Locations
- Locations (1)
Mereo Research Site
🇬🇧Newcastle, United Kingdom