A 6 Month Safety Extension Study of MBGS205

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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A 6 Month, Double-blind Safety Extension Study of MBGS205

Conditions
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Hypogonadotropic Hypogonadism

Intervention / Treatment
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* Drug: BGS649


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participating in Study MBGS205 and completion of the 24 week treatment period without meeting any discontinuation criteria of Study MBGS205 In opinion of the investigator has been compliant with the requirements of the Study MBGS205 protocol. Exclusion Criteria: -Meeting any of the discontinuation criteria of initial Study MBGS205

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGS649 0.1 mg<br>Drug: BGS649 Dose 1 weekly | Drug: BGS649<br>* Capsules will be taken weekly for a maximum of 24 weeks<br>* Other names: Leflutrozole;|
| Experimental: BGS649 0.3 mg<br>Drug: BGS649 Dose 2 weekly | Drug: BGS649<br>* Capsules will be taken weekly for a maximum of 24 weeks<br>* Other names: Leflutrozole;|
| Experimental: BGS649 1.0 mg<br>Drug: BGS649 Dose 3 weekly | Drug: BGS649<br>* Capsules will be taken weekly for a maximum of 24 weeks<br>* Other names: Leflutrozole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 48 weeks compared to baseline in MBGS205 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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). | 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. | 48 Weeks | 
| 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 | 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 | 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) | 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 | 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 | 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. | 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. | 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 | 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. | 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. | 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). | 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. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypogonadotropic, hypogonadism, testosterone