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Completed

NCT Number: NCT02908074

A 6 Month 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)

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Key information

Conditions

Hypogonadotropic Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mereo Research Site, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGS649

Drug

Capsules will be taken weekly for a maximum of 24 weeks

Other names: Leflutrozole

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

    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.

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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.

  5. 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

  6. 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

  7. 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)

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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).

  16. 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.

Sponsors and collaborators

Lead sponsor

Mereo BioPharma

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2016
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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