Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)
This is a 6 months, active treatment, extension study, open to subjects who have completed full 24 weeks in Study MBGS205 (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 \[HH\]).The main purpose of Study MBGS206 is to evaluate long term safety and efficacy parameters in subjects after 12 months exposure with BGS649.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
143
Capsules will be taken weekly for a maximum of 24 weeks
Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Percentage change in lumbar bone mineral density measured by DEXA (g/cm\^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in participants randomised to active treatment in MBGS205.
Time frame: At 48 weeks compared to baseline in MBGS205
Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)
Percentage change from baseline in hip (total and femoral neck) bone mineral density measured by DEXA (g/cm\^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time frame: 48 Weeks
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205
Percentage change from baseline in bone turnover markers (C-terminal telopeptide \[CTx1\], osteocalcin, bone alkaline phosphatase, and procollagen type 1 N-propeptide \[P1NP\]) from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time frame: 48 Weeks
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location
Proportion of subjects with DEXA scan T- scores ≤ -2.5 at Week 48 in MBGS206 compared to baseline in MBGS205 by body location (using overread scan images).
Time frame: 48 Weeks
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency
Percentage change from baseline in bone density and bone biomarkers for vitamin D deficiency from Baseline in Study MBGS205 to Week 48 in Study MBGS206. Bone mineral density (g/cm\^2) measured by DEXA over-read by a central reader.
Time frame: 48 Weeks
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Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48
Descriptive Summary of Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205
Time frame: 48 Weeks
Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48
Descriptive Summary of Percentage Change in Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205
Time frame: 48 Weeks
Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205
Proportion of subjects that overshoot testosterone (total testosterone above 1000 ng/dl \[35 nmol/L\], from first dose of study drug in Study MBGS205 until study completion)
Time frame: 48 Weeks
Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Summary of Laboratory Test Results and Change from Baseline: PSA for Subjects Randomised to Active Treatment in Study MBGS205
Time frame: 48 Weeks
Change From Baseline in Haematocrit at Week 48
Change from baseline in haematocrit from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time frame: 48 Weeks
Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205
Change from baseline in blood pressure (systolic and diastolic measured in mmHg) Baseline in Study MBGS205 to Week 48 in Study MBGS206.
Time frame: 48 Weeks
Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48
Percentage of subjects where bioavailable testosterone was normalised at week 48 in Study MBGS206. Where normalisation was considered testosterone in the range 300-1000 mg/dL.
Time frame: 48 Weeks
Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205
Change from baseline in total, free and bioavailable testosterone from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time frame: 48 Weeks
Change From Baseline in Free and Bioavailable Testosterone
Change from baseline in free and bioavailable (total) testosterone from baseline in Study MBGS205 to Week 48 in Study MBGS206.
Time frame: 48 Weeks
Change From Baseline in Luteinizing Hormone From Baseline to Week 48
Change from baseline of LH from Baseline in Study MBGS205 to Week 48 in Study MBGS206.
Time frame: 48 Weeks
Change From Baseline in Follicle Stimulating Hormone at Week 48
Change from Baseline in Study MBGS205 to Week 48 in Study MBGS206 in follicle stimulating hormone (FSH).
Time frame: 48 Weeks
Percentage Change in Bone Alkaline Phosphatase
Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.
Time frame: 48 weeks