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

NCT02730169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2022-09-14

Study results available
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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.

Conditions

  • Hypogonadotropic Hypogonadism

Interventions

DRUG

BGS649

Capsules were taken weekly for a maximum of 24 weeks

DRUG

Placebo

Capsules were taken weekly for a maximum of 24 weeks

Sponsors & Collaborators

  • Mereo BioPharma

    lead INDUSTRY

Principal Investigators

  • Hugh Jones · Barnsley Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-12
Primary Completion
2018-02-15
Completion
2018-05-19

Countries

  • United States
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730169 on ClinicalTrials.gov