Safety and efficacy of BGS649 in male obese patients with HH
Research type
Research Study
Full 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
IRAS ID
199977
Contact name
Thomas Hugh Jones
Contact email
Sponsor organisation
Mereo BioPharma
Eudract number
2015-005760-42
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
This is a phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group study of 36-week total duration evaluating safety and efficacy of BGS649 in male obese patients with hypogonadotropic hypogonadism ( HH). This study will investigate the efficacy of different weekly oral doses of BGS649, (0.1 mg, 0.3 mg, and 1.0 mg) versus matching placebo in normalising testosterone levels in ≥ 75% of a population of obese men with HH over a 24-week treatment period. Patients will be randomised to three treatment arms of doses of: 0.1 mg, 0.3 mg, and 1.0 mg of BGS649 or matching placebo. If any of the three active treatment arms is found to be ineffective, or is considered unsafe per the data monitoring committee (DMC), dosing for the ineffective or unsafe arm(s) will be stopped.Study participation will comprise up to 2 Screening Visits, 8 visits during the treatment period up to Week 24 (End of Treatment EOT), Visits 9 and 10 for seminal fluid pharmacokinetics (PK described as what the body does to a drug, the movement of drug into, through, and out of the body) measurement (except for subjects who are vasectomised or have vasectomy planned during the study period) and a FU visit (Visit 11) for safety performed 12 weeks after Visit 8 (EOT). PK in seminal fluid will be performed at Visits 8, 9, 10, and 11. A minimum of 25 subjects per arm will be offered a 6 month extension study (Protocol MBGS206), starting at Visit 8 (EOT). Subjects participating in the extension will have their last study visit at Visit 8 and will not participate in seminal fluid PK measurement at Visits 9, 10, and 11.
The study is planned to enrol 268 subjects in a few countries.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0203
Date of REC Opinion
25 May 2016
REC opinion
Further Information Favourable Opinion