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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
143

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mereo BioPharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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