Clinical trial NCT02908074: A 6 Month Safety Extension Study of MBGS205
Official title: A 6 Month, Double-blind Safety Extension Study of MBGS205
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadotropic Hypogonadism
Keywords: Hypogonadotropic
hypogonadism
testosterone
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 143
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206
timeFrame: At 48 weeks compared to baseline in MBGS205
Secondary outcomes:
measure: Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)
timeFrame: 48 Weeks
measure: Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205
timeFrame: 48 Weeks
measure: Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location
timeFrame: 48 Weeks
measure: Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency
timeFrame: 48 Weeks
measure: Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48
timeFrame: 48 Weeks
measure: Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48
timeFrame: 48 Weeks
measure: Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205
timeFrame: 48 Weeks
measure: Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206
timeFrame: 48 Weeks
measure: Change From Baseline in Haematocrit at Week 48
timeFrame: 48 Weeks
measure: Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205
timeFrame: 48 Weeks
measure: Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48
timeFrame: 48 Weeks
measure: Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205
timeFrame: 48 Weeks
measure: Change From Baseline in Free and Bioavailable Testosterone
timeFrame: 48 Weeks
measure: Change From Baseline in Luteinizing Hormone From Baseline to Week 48
timeFrame: 48 Weeks
measure: Change From Baseline in Follicle Stimulating Hormone at Week 48
timeFrame: 48 Weeks
measure: Percentage Change in Bone Alkaline Phosphatase
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mereo Research Site
state: Alabama
city: Chandler
country: United States
facility: Mereo Research Site
state: Arizona
city: Phoenix
country: United States
facility: Mereo Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Mereo Research Site
state: Arizona
city: Anaheim
country: United States
facility: Mereo Research Site
state: California
city: Greenbrae
country: United States
facility: Mereo Research Site
state: California
city: Lincoln
country: United States
facility: Mereo Research Site
state: California
city: Los Angeles
country: United States
facility: Mereo Research Site
state: California
city: San Diego
country: United States
facility: Mereo Research Site
state: California
city: Bradenton
country: United States
facility: Mereo Research Site
state: Florida
city: DeLand
country: United States
facility: Mereo Research Site
state: Florida
city: Fort Myers
country: United States
facility: Mereo Research Site
state: Florida
city: Hialeah
country: United States
facility: Mereo Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Mereo Research Site
state: Florida
city: Meridian
country: United States
facility: Mereo Research Site
state: Idaho
city: Evansville
country: United States
facility: Mereo Research Site
state: Indiana
city: Marrero
country: United States
facility: Mereo Research Site
state: Louisiana
city: Elkridge
country: United States
facility: Mereo Research Site
state: Maryland
city: Henderson
country: United States
facility: Mereo Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Mereo Research Site
state: Nevada
city: Albany
country: United States
facility: Mereo Research Site
state: New York
city: Garden City
country: United States
facility: Mereo Research Site
state: New York
city: Great Neck
country: United States
facility: Mereo Research Site
state: New York
city: New York
country: United States
facility: Mereo Research Site
state: New York
city: Rochester
country: United States
facility: Mereo Research Site
state: New York
city: Charlotte
country: United States
facility: Mereo Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Mereo Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Mereo Research Site
state: North Carolina
city: Mount Pleasant
country: United States
facility: Mereo Research Site
state: South Carolina
city: Nashville
country: United States
facility: Mereo Research Site
state: Tennessee
city: Dallas
country: United States
facility: Mereo Research Site
state: Texas
city: Fort Worth
country: United States
facility: Mereo Research Site
state: Texas
city: Pearland
country: United States
facility: Mereo Research Site
state: Texas
city: San Antonio
country: United States
facility: Mereo Research Site
state: Texas
city: West Jordan
country: United States
facility: Mereo Research Site
state: Utah
city: Norfolk
country: United States
facility: Mereo Research Site
state: Virginia
city: Kenosha
country: United States
facility: Mereo Research Site
state: Wisconsin
Study officials:
affiliation: Barnsley Hospital NHS Foundation Trust
name: Hugh Jones
role: PRINCIPAL_INVESTIGATOR
References: