A 6 Month Safety Extension Study of MBGS205 | NCT02908074 | Trialant
NCT02908074
Sponsor
Mereo BioPharma
Status
Completed
Last Update Posted
May 18, 2023Actual
Enrollment
143Actual
Phase
Phase 2
Conditions
Hypogonadotropic Hypogonadism
Interventions
BGS649
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02908074
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MBGS206
Secondary IDs
Not provided
Brief Title
A 6 Month Safety Extension Study of MBGS205
Official Title
A 6 Month, Double-blind Safety Extension Study of MBGS205
Acronym
Not provided
Organization
Mereo BioPharmaINDUSTRY
Status Module
Record Verification Date
Apr 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 15, 2016Actual
Primary Completion Date
Sep 8, 2018Actual
Completion Date
Nov 21, 2018Actual
First Submitted Date
Sep 12, 2016
First Submission Date that Met QC Criteria
Sep 16, 2016
First Posted Date
Sep 20, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 9, 2020
Results First Submitted that Met QC Criteria
Apr 24, 2023
Results First Posted Date
May 18, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 24, 2023
Last Update Posted Date
May 18, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Mereo BioPharmaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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
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.
Conditions Module
Conditions
Hypogonadotropic Hypogonadism
Keywords
Hypogonadotropic
hypogonadism
testosterone
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
143Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BGS649 0.1 mg
Experimental
Drug: BGS649 Dose 1 weekly
Drug: BGS649
BGS649 0.3 mg
Experimental
Drug: BGS649 Dose 2 weekly
Drug: BGS649
BGS649 1.0 mg
Experimental
Drug: BGS649 Dose 3 weekly
Drug: BGS649
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BGS649
Drug
Capsules will be taken weekly for a maximum of 24 weeks
BGS649 0.1 mg
BGS649 0.3 mg
BGS649 1.0 mg
Outcomes Module
Primary Outcomes
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 Outcomes
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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Hugh Jones
Barnsley Hospital NHS Foundation Trust
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mereo Research Site
Mobile
Alabama
United States
Mereo Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants receiving active doses of BGS649 in Study MBGS205 continued with the same dose in Study MBGS206; Participants receiving placebo in Study MBGS205 were re-randomised at the Baseline visit to receive one of the 3 treatment regimens (BGS649 0.1 mg, 0.3 mg, and 1.0 mg) in a 1:1:1 ratio, and were only assessed for safety in study MBGS206.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
FG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 28, 2017
Sep 9, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Leflutrozole
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
Chandler
Arizona
United States
Mereo Research Site
Phoenix
Arizona
United States
Mereo Research Site
Scottsdale
Arizona
United States
Mereo Research Site
Anaheim
California
United States
Mereo Research Site
Greenbrae
California
United States
Mereo Research Site
Lincoln
California
United States
Mereo Research Site
Los Angeles
California
United States
Mereo Research Site
San Diego
California
United States
Mereo Research Site
Bradenton
Florida
United States
Mereo Research Site
DeLand
Florida
United States
Mereo Research Site
Fort Myers
Florida
United States
Mereo Research Site
Hialeah
Florida
United States
Mereo Research Site
St. Petersburg
Florida
United States
Mereo Research Site
Meridian
Idaho
United States
Mereo Research Site
Evansville
Indiana
United States
Mereo Research Site
Marrero
Louisiana
United States
Mereo Research Site
Elkridge
Maryland
United States
Mereo Research Site
Henderson
Nevada
United States
Mereo Research Site
Las Vegas
Nevada
United States
Mereo Research Site
Albany
New York
United States
Mereo Research Site
Garden City
New York
United States
Mereo Research Site
Great Neck
New York
United States
Mereo Research Site
New York
New York
United States
Mereo Research Site
Rochester
New York
United States
Mereo Research Site
Charlotte
North Carolina
United States
Mereo Research Site
Raleigh
North Carolina
United States
Mereo Research Site
Winston-Salem
North Carolina
United States
Mereo Research Site
Mt. Pleasant
South Carolina
United States
Mereo Research Site
Nashville
Tennessee
United States
Mereo Research Site
Dallas
Texas
United States
Mereo Research Site
Fort Worth
Texas
United States
Mereo Research Site
Pearland
Texas
United States
Mereo Research Site
San Antonio
Texas
United States
Mereo Research Site
West Jordan
Utah
United States
Mereo Research Site
Norfolk
Virginia
United States
Mereo Research Site
Kenosha
Wisconsin
United States
FG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
FG003
Placebo to BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
FG004
Placebo to BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
FG005
Placebo to BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
FG00038 subjects
FG00133 subjects
FG00231 subjects
FG00313 subjects
FG00417 subjects
FG00511 subjects
Received at Least 1 Dose of Study Drug
FG00038 subjects
FG00133 subjects
FG00230 subjects
FG00313 subjects
FG00417 subjects
FG00510 subjects
Safety Population
FG00038 subjects
FG00133 subjects
FG00230 subjects
FG00313 subjects
FG00417 subjects
FG00510 subjects
Intention-to-treat (ITT) Population
FG00038 subjects
FG00133 subjects
FG00230 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00029 subjects
FG00127 subjects
FG00225 subjects
FG00310 subjects
FG00413 subjects
FG0057 subjects
NOT COMPLETED
FG0009 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
Type
Comment
Reasons
sponsor/ICON decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0005 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
AESI
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Discontinuation criteria per protocol
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
The safety population included all participants who received at least 1 administration of the study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG003
Placebo to BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG004
Placebo to BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG005
Placebo to BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00038
BG00133
BG00230
BG00313
BG00417
BG00510
BG006141
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.2± 7.34
BG00151.9± 7.76
BG00250.0± 9.98
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
The Intention-to-treat (ITT) population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine bone mineral density (BMD) measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Percentage change
At 48 weeks compared to baseline in MBGS205
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
Units
Counts
Participants
OG00021
OG00116
OG00216
Title
Denominators
Categories
Title
Measurements
OG000-2.24± 3.157
OG001-3.31± 5.301
OG002-1.68± 3.095
Secondary
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
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percentage of change
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
Secondary
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
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ug/L
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
Secondary
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).
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number analyzed" is the number of participants evaluated for each location.
Posted
Count of Participants
Participants
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
Secondary
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.
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number analyzed" is the number of participants evaluated for each location.
Posted
Mean
Standard Deviation
percentage change from baseline in DEXA
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
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
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Oestradiol (pg/mL)
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
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
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percentage from baseline at Week 48
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
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)
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
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
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Prostate Specific Antigen (ug/L)
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
Change From Baseline in Haematocrit at Week 48
Change from baseline in haematocrit from Baseline in Study MBGS205 to Week 48 in Study MBGS206
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
RATIO (Change)
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Units
Secondary
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.
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Blood Pressure (mmHg) (Change)
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
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.
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003
Secondary
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
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Total Testosterone (ng/dL) Change
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
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.
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
(ng/dL) and (ng/L), respectively
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003
Placebo to BGS649 0.1 mg
Secondary
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.
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Luteinizing Hormone (mIU/mL)
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003
Placebo to BGS649 0.1 mg
Secondary
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).
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Follicle Stimulating Hormone (mIU/mL)
48 Weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Secondary
Percentage Change in Bone Alkaline Phosphatase
Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.
The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
U/L
48 weeks
ID
Title
Description
OG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206
OG003
Time Frame
Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up)
Description
The safety population included all participants who received at least 1 administration of the study medication.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
0
38
1
38
27
38
EG001
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
1
33
2
33
23
33
EG002
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
0
30
1
30
25
30
EG003
Placebo to BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
0
13
0
13
10
13
EG004
Placebo to BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks
0
17
0
17
12
17
EG005
Placebo to BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
BGS649: Capsules will be taken weekly for a maximum of 24 weeks