A 6 Month Safety Extension Study of MBGS205

Mereo BioPharma

Status and phase: Completed; Phase 2

Conditions: Hypogonadotropic Hypogonadism

Treatments: Drug: BGS649

Study type: Interventional

Funder types: Industry

Identifiers

NCT02908074

MBGS206

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 143 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

143 participants in 3 patient groups

BGS649 0.1 mg

Experimental group

Description:

Drug: BGS649 Dose 1 weekly

Treatment:

Drug: BGS649

BGS649 0.3 mg

Experimental group

Description:

Drug: BGS649 Dose 2 weekly

Treatment:

Drug: BGS649

BGS649 1.0 mg

Experimental group

Description:

Drug: BGS649 Dose 3 weekly

Treatment:

Drug: BGS649