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Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

NCT01200862 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-10-08

Study results available
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Summary

This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men

Conditions

  • Obese Hypogonadotropic Hypogonadism

Interventions

DRUG

Investigational new drug company code: BGS649

DRUG

Placebo

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Mereo BioPharma

    lead INDUSTRY

Principal Investigators

  • Jacqueline Parkin, PhD FRCP · Mereo BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01200862 on ClinicalTrials.gov