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Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

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ClinicalTrials.gov Identifier: NCT02730169
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : May 19, 2018

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

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

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

Placebo Comparator: Regimen 4
Placebo weekly
Drug: Placebo
Capsules will be taken weekly for a maximum of 24 weeks




Primary Outcome Measures :
  1. Proportion (percentage) of BGS649 treated subjects with serum concentration of total testosterone in the normal range 300-1000 ng/dL [10.4-35 nmol/L]) after 24 weeks of treatment. [ Time Frame: 24 weeks of treatment ]


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:

  • Adult male subject aged 18 to 65 years inclusive
  • BMI > 30 kg/m2 and < 50 kg/m2
  • Serum total testosterone concentration below the normal range
  • LH levels below the upper limit of normal
  • Oestradiol levels within or above the normal range of approved assay
  • At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction

Exclusion Criteria:

  • Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
  • Other types of hypogonadotropic hypogonadism or primary hypogonadism
  • Any other pituitary or hypothalamic disease

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): NCT02730169


  Show 63 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: NCT02730169     History of Changes
Other Study ID Numbers: MBGS205
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mereo BioPharma:
Hypogonadotropic
hypogonadism
testosterone
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases