Phase 2 N=143 Randomized Double-blind Treatment

A 6 Month Safety Extension Study of MBGS205

Hypogonadotropic Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT02908074 ↗

Enrolled (actual)

143

Serious AEs

2.8%

Results posted

May 2023

Primary outcome: Primary: Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206 — -2.24; -3.31; -1.68 Percentage change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BGS649 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Mereo BioPharma
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206	-2.24; -3.31; -1.68	—
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)	0.01; -1.71; 0.61; -1.09; -2.60; -0.15	—
SECONDARY Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205	83.28; 64.42; 57.91; 40.40; 37.62; 34.17	—
SECONDARY Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency	-0.86; -1.81; 1.22; -0.78; 0.09; 4.36	—
SECONDARY Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48	-12.750; -11.852; -12.917	—
SECONDARY Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48	-39.54; -47.00; -48.30	—
SECONDARY Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205	0; 0; 2	—
SECONDARY Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206	0.163; 0.164; 0.169	—
SECONDARY Change From Baseline in Haematocrit at Week 48	0.0128; 0.0136; 0.0286	—
SECONDARY Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205	2.7; 2.6; -0.7; -0.2; 1.1; 1.6	—
SECONDARY Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48	25; 17; 19; 6; 11; 5	—
SECONDARY Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205	241.0; 290.6; 378.9	—
SECONDARY Change From Baseline in Free and Bioavailable Testosterone	162.12; 191.23; 255.57; 168.71; 240.25; 255.27	—
SECONDARY Change From Baseline in Luteinizing Hormone From Baseline to Week 48	2.683; 3.665; 3.613; 3.973; 4.834; 2.720	—
SECONDARY Change From Baseline in Follicle Stimulating Hormone at Week 48	5.473; 7.509; 6.781	—
SECONDARY Percentage Change in Bone Alkaline Phosphatase	12.67; 3.85; 15.28; 14.46; -3.40; 3.80	—

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)

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02908074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.