A 6 Month Safety Extension Study of MBGS205

April 24, 2023 updated by: Mereo BioPharma

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
        • Mereo Research Site
    • Arizona
      • Chandler, Arizona, United States
        • Mereo Research Site
      • Phoenix, Arizona, United States
        • Mereo Research Site
      • Scottsdale, Arizona, United States
        • Mereo Research Site
    • California
      • 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
    • Florida
      • 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
      • Saint Petersburg, Florida, United States
        • Mereo Research Site
    • Idaho
      • Meridian, Idaho, United States
        • Mereo Research Site
    • Indiana
      • Evansville, Indiana, United States
        • Mereo Research Site
    • Louisiana
      • Marrero, Louisiana, United States
        • Mereo Research Site
    • Maryland
      • Elkridge, Maryland, United States
        • Mereo Research Site
    • Nevada
      • Henderson, Nevada, United States
        • Mereo Research Site
      • Las Vegas, Nevada, United States
        • Mereo Research Site
    • New York
      • 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
    • North Carolina
      • 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
    • South Carolina
      • Mount Pleasant, South Carolina, United States
        • Mereo Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Mereo Research Site
    • Texas
      • 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
    • Utah
      • West Jordan, Utah, United States
        • Mereo Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Mereo Research Site
    • Wisconsin
      • Kenosha, Wisconsin, United States
        • Mereo Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks
Other Names:
  • Leflutrozole
Experimental: BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks
Other Names:
  • Leflutrozole
Experimental: BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks
Other Names:
  • Leflutrozole

What is the study measuring?

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
Time Frame: At 48 weeks compared to baseline in MBGS205
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)
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 Weeks
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
Time Frame: 48 weeks
Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mereo BioPharma

Investigators

  • Principal Investigator: Hugh Jones, Barnsley Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2016

Primary Completion (Actual)

September 8, 2018

Study Completion (Actual)

November 21, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBGS206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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