A 6 Month Safety Extension Study of MBGS205

NCT ID: NCT02908074

Last Updated: 2023-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2018-11-21

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Hypogonadotropic Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BGS649 0.1 mg

Drug: BGS649 Dose 1 weekly

Group Type EXPERIMENTAL

BGS649

Intervention Type DRUG

Capsules will be taken weekly for a maximum of 24 weeks

BGS649 0.3 mg

Drug: BGS649 Dose 2 weekly

Group Type EXPERIMENTAL

BGS649

Intervention Type DRUG

Capsules will be taken weekly for a maximum of 24 weeks

BGS649 1.0 mg

Drug: BGS649 Dose 3 weekly

Group Type EXPERIMENTAL

BGS649

Intervention Type DRUG

Capsules will be taken weekly for a maximum of 24 weeks

Interventions

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BGS649

Capsules will be taken weekly for a maximum of 24 weeks

Intervention Type DRUG

Other Intervention Names

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Leflutrozole

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mereo BioPharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugh Jones

Role: PRINCIPAL_INVESTIGATOR

Barnsley Hospital NHS Foundation Trust

Locations

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Mereo Research Site

Mobile, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Anaheim, California, United States

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Greenbrae, California, United States

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Lincoln, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Bradenton, Florida, United States

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DeLand, Florida, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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St. Petersburg, Florida, United States

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Meridian, Idaho, United States

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Evansville, Indiana, United States

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Marrero, Louisiana, United States

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Elkridge, Maryland, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Albany, New York, United States

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Garden City, New York, United States

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Great Neck, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Kenosha, Wisconsin, United States

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Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MBGS206

Identifier Type: -

Identifier Source: org_study_id

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