A 6 Month Safety Extension Study of MBGS205
A 6 Month, Double-blind Safety Extension Study of MBGS205
1 other identifier
interventional
143
1 country
37
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedStudy Start
First participant enrolled
November 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2018
CompletedResults Posted
Study results publicly available
May 18, 2023
CompletedMay 18, 2023
April 1, 2023
1.8 years
September 12, 2016
September 9, 2020
April 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (16)
Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)
48 Weeks
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205
48 Weeks
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location
48 Weeks
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency
48 Weeks
Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48
48 Weeks
- +11 more secondary outcomes
Study Arms (3)
BGS649 0.1 mg
EXPERIMENTALDrug: BGS649 Dose 1 weekly
BGS649 0.3 mg
EXPERIMENTALDrug: BGS649 Dose 2 weekly
BGS649 1.0 mg
EXPERIMENTALDrug: BGS649 Dose 3 weekly
Interventions
Capsules will be taken weekly for a maximum of 24 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Meeting any of the discontinuation criteria of initial Study MBGS205
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mereo BioPharmalead
Study Sites (37)
Mereo Research Site
Mobile, Alabama, United States
Mereo Research Site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jackie Parkin
- Organization
- Mereo BioPharma Group
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh Jones
Barnsley Hospital NHS Foundation Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2016
First Posted
September 20, 2016
Study Start
November 15, 2016
Primary Completion
September 8, 2018
Study Completion
November 21, 2018
Last Updated
May 18, 2023
Results First Posted
May 18, 2023
Record last verified: 2023-04