A 6 Month Safety Extension Study of MBGS205
Sponsor
Mereo BioPharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02908074
Collaborator
(none)
143
37
3
24.2
3.9
0.2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 6 Month, Double-blind Safety Extension Study of MBGS205
Actual Study Start Date
:
Nov 15, 2016
Actual Primary Completion Date
:
Sep 8, 2018
Actual Study Completion Date
:
Nov 21, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: Regimen 1 Drug: BGS649 Dose 1 weekly |
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks
|
| Experimental: Experimental: Regimen 2 Drug: BGS649 Dose 2 weekly |
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks
|
| Experimental: Experimental: Regimen 3 Drug: BGS649 Dose 3 weekly |
Drug: BGS649
Capsules will be taken weekly for a maximum of 24 weeks
|
Outcome Measures
Primary Outcome Measures
- The effect on bone mineral density measured by DEXA (g/cm2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in subjects randomised to active treatment in Study MBGS205. [48 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mereo Research Site | Mobile | Alabama | United States | |
| 2 | Mereo Research Site | Chandler | Arizona | United States | |
| 3 | Mereo Research Site | Phoenix | Arizona | United States | |
| 4 | Mereo Research Site | Scottsdale | Arizona | United States | |
| 5 | Mereo Research Site | Anaheim | California | United States | |
| 6 | Mereo Research Site | Greenbrae | California | United States | |
| 7 | Mereo Research Site | Lincoln | California | United States | |
| 8 | Mereo Research Site | Los Angeles | California | United States | |
| 9 | Mereo Research Site | San Diego | California | United States | |
| 10 | Mereo Research Site | Bradenton | Florida | United States | |
| 11 | Mereo Research Site | DeLand | Florida | United States | |
| 12 | Mereo Research Site | Fort Myers | Florida | United States | |
| 13 | Mereo Research Site | Hialeah | Florida | United States | |
| 14 | Mereo Research Site | Saint Petersburg | Florida | United States | |
| 15 | Mereo Research Site | Meridian | Idaho | United States | |
| 16 | Mereo Research Site | Evansville | Indiana | United States | |
| 17 | Mereo Research Site | Marrero | Louisiana | United States | |
| 18 | Mereo Research Site | Elkridge | Maryland | United States | |
| 19 | Mereo Research Site | Henderson | Nevada | United States | |
| 20 | Mereo Research Site | Las Vegas | Nevada | United States | |
| 21 | Mereo Research Site | Albany | New York | United States | |
| 22 | Mereo Research Site | Garden City | New York | United States | |
| 23 | Mereo Research Site | Great Neck | New York | United States | |
| 24 | Mereo Research Site | New York | New York | United States | |
| 25 | Mereo Research Site | Rochester | New York | United States | |
| 26 | Mereo Research Site | Charlotte | North Carolina | United States | |
| 27 | Mereo Research Site | Raleigh | North Carolina | United States | |
| 28 | Mereo Research Site | Winston-Salem | North Carolina | United States | |
| 29 | Mereo Research Site | Mount Pleasant | South Carolina | United States | |
| 30 | Mereo Research Site | Nashville | Tennessee | United States | |
| 31 | Mereo Research Site | Dallas | Texas | United States | |
| 32 | Mereo Research Site | Fort Worth | Texas | United States | |
| 33 | Mereo Research Site | Pearland | Texas | United States | |
| 34 | Mereo Research Site | San Antonio | Texas | United States | |
| 35 | Mereo Research Site | West Jordan | Utah | United States | |
| 36 | Mereo Research Site | Norfolk | Virginia | United States | |
| 37 | Mereo Research Site | Kenosha | Wisconsin | United States |
Sponsors and Collaborators
- Mereo BioPharma
Investigators
- Principal Investigator: Hugh Jones, Barnsley Hospital NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mereo BioPharma
ClinicalTrials.gov Identifier:
NCT02908074
Other Study ID Numbers:
- MBGS206
First Posted:
Sep 20, 2016
Last Update Posted:
Dec 6, 2018
Last Verified:
Dec 1, 2018
Keywords provided by Mereo BioPharma
Additional relevant MeSH terms: