A 6 Month Safety Extension Study of MBGS205

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

A 6 Month, Double-blind Safety Extension Study of MBGS205

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908074
• Other study ID #: MBGS206
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2016
• Est. completion date: November 21, 2018

Study information

• Verified date: April 2023
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 21, 2018
• Est. primary completion date: September 8, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism

Intervention

Drug:
• BGS649
Capsules will be taken weekly for a maximum of 24 weeks

Locations

Country	Name	City	State
United States	Mereo Research Site	Albany	New York
United States	Mereo Research Site	Anaheim	California
United States	Mereo Research Site	Bradenton	Florida
United States	Mereo Research Site	Chandler	Arizona
United States	Mereo Research Site	Charlotte	North Carolina
United States	Mereo Research Site	Dallas	Texas
United States	Mereo Research Site	DeLand	Florida
United States	Mereo Research Site	Elkridge	Maryland
United States	Mereo Research Site	Evansville	Indiana
United States	Mereo Research Site	Fort Myers	Florida
United States	Mereo Research Site	Fort Worth	Texas
United States	Mereo Research Site	Garden City	New York
United States	Mereo Research Site	Great Neck	New York
United States	Mereo Research Site	Greenbrae	California
United States	Mereo Research Site	Henderson	Nevada
United States	Mereo Research Site	Hialeah	Florida
United States	Mereo Research Site	Kenosha	Wisconsin
United States	Mereo Research Site	Las Vegas	Nevada
United States	Mereo Research Site	Lincoln	California
United States	Mereo Research Site	Los Angeles	California
United States	Mereo Research Site	Marrero	Louisiana
United States	Mereo Research Site	Meridian	Idaho
United States	Mereo Research Site	Mobile	Alabama
United States	Mereo Research Site	Mount Pleasant	South Carolina
United States	Mereo Research Site	Nashville	Tennessee
United States	Mereo Research Site	New York	New York
United States	Mereo Research Site	Norfolk	Virginia
United States	Mereo Research Site	Pearland	Texas
United States	Mereo Research Site	Phoenix	Arizona
United States	Mereo Research Site	Raleigh	North Carolina
United States	Mereo Research Site	Rochester	New York
United States	Mereo Research Site	Saint Petersburg	Florida
United States	Mereo Research Site	San Antonio	Texas
United States	Mereo Research Site	San Diego	California
United States	Mereo Research Site	Scottsdale	Arizona
United States	Mereo Research Site	West Jordan	Utah
United States	Mereo Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mereo BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206	Percentage change in lumbar bone mineral density measured by DEXA (g/cm^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in participants randomised to active treatment in MBGS205.	At 48 weeks compared to baseline in MBGS205
Secondary	Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)	Percentage change from baseline in hip (total and femoral neck) bone mineral density measured by DEXA (g/cm^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206	48 Weeks
Secondary	Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205	Percentage change from baseline in bone turnover markers (C-terminal telopeptide [CTx1], osteocalcin, bone alkaline phosphatase, and procollagen type 1 N-propeptide [P1NP]) from Baseline in Study MBGS205 to Week 48 in Study MBGS206	48 Weeks
Secondary	Percentage of Subjects With DEXA Scan T-score = -2.5 at Week 48 by Location	Proportion of subjects with DEXA scan T- scores = -2.5 at Week 48 in MBGS206 compared to baseline in MBGS205 by body location (using overread scan images).	48 Weeks
Secondary	Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency	Percentage change from baseline in bone density and bone biomarkers for vitamin D deficiency from Baseline in Study MBGS205 to Week 48 in Study MBGS206. Bone mineral density (g/cm^2) measured by DEXA over-read by a central reader.	48 Weeks
Secondary	Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48	Descriptive Summary of Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205	48 Weeks
Secondary	Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48	Descriptive Summary of Percentage Change in Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205	48 Weeks
Secondary	Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205	Proportion of subjects that overshoot testosterone (total testosterone above 1000 ng/dl [35 nmol/L], from first dose of study drug in Study MBGS205 until study completion)	48 Weeks
Secondary	Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206	Summary of Laboratory Test Results and Change from Baseline: PSA for Subjects Randomised to Active Treatment in Study MBGS205	48 Weeks
Secondary	Change From Baseline in Haematocrit at Week 48	Change from baseline in haematocrit from Baseline in Study MBGS205 to Week 48 in Study MBGS206	48 Weeks
Secondary	Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205	Change from baseline in blood pressure (systolic and diastolic measured in mmHg) Baseline in Study MBGS205 to Week 48 in Study MBGS206.	48 Weeks
Secondary	Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48	Percentage of subjects where bioavailable testosterone was normalised at week 48 in Study MBGS206. Where normalisation was considered testosterone in the range 300-1000 mg/dL.	48 Weeks
Secondary	Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205	Change from baseline in total, free and bioavailable testosterone from Baseline in Study MBGS205 to Week 48 in Study MBGS206	48 Weeks
Secondary	Change From Baseline in Free and Bioavailable Testosterone	Change from baseline in free and bioavailable (total) testosterone from baseline in Study MBGS205 to Week 48 in Study MBGS206.	48 Weeks
Secondary	Change From Baseline in Luteinizing Hormone From Baseline to Week 48	Change from baseline of LH from Baseline in Study MBGS205 to Week 48 in Study MBGS206.	48 Weeks
Secondary	Change From Baseline in Follicle Stimulating Hormone at Week 48	Change from Baseline in Study MBGS205 to Week 48 in Study MBGS206 in follicle stimulating hormone (FSH).	48 Weeks
Secondary	Percentage Change in Bone Alkaline Phosphatase	Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.	48 weeks