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A 6 Month Safety Extension Study of MBGS205

Primary Purpose

Hypogonadotropic Hypogonadism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BGS649
Sponsored by
Mereo BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring Hypogonadotropic, hypogonadism, testosterone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BGS649 0.1 mg

BGS649 0.3 mg

BGS649 1.0 mg

Arm Description

Drug: BGS649 Dose 1 weekly

Drug: BGS649 Dose 2 weekly

Drug: BGS649 Dose 3 weekly

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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).
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.
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
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
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)
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
Change From Baseline in Haematocrit at Week 48
Change from baseline in haematocrit from Baseline in Study MBGS205 to Week 48 in Study MBGS206
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.
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.
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
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.
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.
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).
Percentage Change in Bone Alkaline Phosphatase
Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.

Full Information

First Posted
September 12, 2016
Last Updated
April 24, 2023
Sponsor
Mereo BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT02908074
Brief Title
A 6 Month Safety Extension Study of MBGS205
Official Title
A 6 Month, Double-blind Safety Extension Study of MBGS205
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
September 8, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mereo BioPharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism
Keywords
Hypogonadotropic, hypogonadism, testosterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGS649 0.1 mg
Arm Type
Experimental
Arm Description
Drug: BGS649 Dose 1 weekly
Arm Title
BGS649 0.3 mg
Arm Type
Experimental
Arm Description
Drug: BGS649 Dose 2 weekly
Arm Title
BGS649 1.0 mg
Arm Type
Experimental
Arm Description
Drug: BGS649 Dose 3 weekly
Intervention Type
Drug
Intervention Name(s)
BGS649
Other Intervention Name(s)
Leflutrozole
Intervention Description
Capsules will be taken weekly for a maximum of 24 weeks
Primary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Description
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
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)
Description
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
Title
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205
Description
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
Title
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location
Description
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
Title
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency
Description
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
Title
Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48
Description
Descriptive Summary of Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205
Time Frame
48 Weeks
Title
Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48
Description
Descriptive Summary of Percentage Change in Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205
Time Frame
48 Weeks
Title
Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205
Description
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
Title
Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Description
Summary of Laboratory Test Results and Change from Baseline: PSA for Subjects Randomised to Active Treatment in Study MBGS205
Time Frame
48 Weeks
Title
Change From Baseline in Haematocrit at Week 48
Description
Change from baseline in haematocrit from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time Frame
48 Weeks
Title
Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205
Description
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
Title
Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48
Description
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
Title
Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205
Description
Change from baseline in total, free and bioavailable testosterone from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time Frame
48 Weeks
Title
Change From Baseline in Free and Bioavailable Testosterone
Description
Change from baseline in free and bioavailable (total) testosterone from baseline in Study MBGS205 to Week 48 in Study MBGS206.
Time Frame
48 Weeks
Title
Change From Baseline in Luteinizing Hormone From Baseline to Week 48
Description
Change from baseline of LH from Baseline in Study MBGS205 to Week 48 in Study MBGS206.
Time Frame
48 Weeks
Title
Change From Baseline in Follicle Stimulating Hormone at Week 48
Description
Change from Baseline in Study MBGS205 to Week 48 in Study MBGS206 in follicle stimulating hormone (FSH).
Time Frame
48 Weeks
Title
Percentage Change in Bone Alkaline Phosphatase
Description
Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.
Time Frame
48 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Jones
Organizational Affiliation
Barnsley Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mereo Research Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Mereo Research Site
City
Chandler
State/Province
Arizona
Country
United States
Facility Name
Mereo Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Mereo Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Mereo Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Greenbrae
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Lincoln
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Mereo Research Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Mereo Research Site
City
Marrero
State/Province
Louisiana
Country
United States
Facility Name
Mereo Research Site
City
Elkridge
State/Province
Maryland
Country
United States
Facility Name
Mereo Research Site
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
Mereo Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Mereo Research Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Mereo Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Mereo Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Mereo Research Site
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Mereo Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Mereo Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
Pearland
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
West Jordan
State/Province
Utah
Country
United States
Facility Name
Mereo Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Mereo Research Site
City
Kenosha
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A 6 Month Safety Extension Study of MBGS205

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