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A 6 Month Safety Extension Study of MBGS205

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ClinicalTrials.gov Identifier: NCT02908074
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypogonadotropic Hypogonadism Drug: BGS649 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 6 Month, Double-blind Safety Extension Study of MBGS205
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : September 8, 2018
Actual Study Completion Date : November 21, 2018

Arm Intervention/treatment
Experimental: Experimental: Regimen 1
Drug: BGS649 Dose 1 weekly
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks

Experimental: Experimental: Regimen 2
Drug: BGS649 Dose 2 weekly
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks

Experimental: Experimental: Regimen 3
Drug: BGS649 Dose 3 weekly
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks




Primary Outcome Measures :
  1. The effect on bone mineral density measured by DEXA (g/cm2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in subjects randomised to active treatment in Study MBGS205. [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908074


  Show 37 Study Locations
Sponsors and Collaborators
Mereo BioPharma
Investigators
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Principal Investigator: Hugh Jones Barnsley Hospital NHS Foundation Trust

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Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT02908074     History of Changes
Other Study ID Numbers: MBGS206
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Keywords provided by Mereo BioPharma:
Hypogonadotropic
hypogonadism
testosterone
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases