Clinical trial NCT02730169: Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadotropic Hypogonadism
Keywords: Hypogonadotropic
hypogonadism
testosterone
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 271
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.


Eligibility criteria: Inclusion Criteria:

* Adult male subject aged 18 to 65 years inclusive
* BMI \> 30 kg/m2 and \< 50 kg/m2
* Serum total testosterone concentration below the normal range
* LH levels below the upper limit of normal
* Oestradiol levels within or above the normal range of approved assay
* At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction

Exclusion Criteria:

* Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
* Other types of hypogonadotropic hypogonadism or primary hypogonadism
* Any other pituitary or hypothalamic disease

Primary outcomes:
measure: Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
timeFrame: 24 weeks of treatment
Secondary outcomes:
measure: The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24
timeFrame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24
timeFrame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.
timeFrame: 24 weeks of treatment
measure: Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.
timeFrame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.
timeFrame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.
timeFrame: Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment
measure: Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.
timeFrame: Week 24 and week 24/End of treatment
Other outcomes:
measure: Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.
timeFrame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Mean (SD) Change From Baseline in Haematocrit to Week 24.
timeFrame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24.
timeFrame: Screening to Week 24
measure: Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24
timeFrame: Screening to Week 24
measure: Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24.
timeFrame: Screening to Week 24
measure: Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.
timeFrame: 24 weeks
Locations:
city: Birmingham
country: United States
facility: Mereo Research Site
state: Alabama
city: Mobile
country: United States
facility: Mereo Research Site
state: Alabama
city: Chandler
country: United States
facility: Mereo Research Site
state: Arizona
city: Phoenix
country: United States
facility: Mereo Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Mereo Research Site
state: Arizona
city: Anaheim
country: United States
facility: Mereo Research Site
state: California
city: Carlsbad
country: United States
facility: Mereo Research Site
state: California
city: Greenbrae
country: United States
facility: Mereo Research Site
state: California
city: Lincoln
country: United States
facility: Mereo Research Site
state: California
city: Los Angeles
country: United States
facility: Mereo Research Site
state: California
city: San Diego
country: United States
facility: Mereo Research Site
state: California
city: Bradenton
country: United States
facility: Mereo Research Site
state: Florida
city: DeLand
country: United States
facility: Mereo Research Site
state: Florida
city: Fort Myers
country: United States
facility: Mereo Research Site
state: Florida
city: Hialeah
country: United States
facility: Mereo Research Site
state: Florida
city: Homestead
country: United States
facility: Mereo Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Mereo Research Site
state: Florida
city: Meridian
country: United States
facility: Mereo Research Site
state: Idaho
city: Gurnee
country: United States
facility: Mereo Research Site
state: Illinois
city: Evansville
country: United States
facility: Mereo Research Site
state: Indiana
city: New Orleans
country: United States
facility: Mereo Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Mereo Research Site
state: Maryland
city: Elkridge
country: United States
facility: Mereo Research Site
state: Maryland
city: Saint Louis
country: United States
facility: Mereo Research Site
state: Missouri
city: Omaha
country: United States
facility: Mereo Research Site
state: Nebraska
city: Henderson
country: United States
facility: Mereo Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Mereo Research Site
state: Nevada
city: Albany
country: United States
facility: Mereo Research Site
state: New York
city: Garden City
country: United States
facility: Mereo Research Site
state: New York
city: Great Neck
country: United States
facility: Mereo Research Site
state: New York
city: New York
country: United States
facility: Mereo Research Site
state: New York
city: Rochester
country: United States
facility: Mereo Research Site
state: New York
city: Charlotte
country: United States
facility: Mereo Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Mereo Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Mereo Research Site
state: North Carolina
city: Middleburg Heights
country: United States
facility: Mereo Research Site
state: Ohio
city: Mount Pleasant
country: United States
facility: Mereo Research Site
state: South Carolina
city: Nashville
country: United States
facility: Mereo Research Site
state: Tennessee
city: Smyrna
country: United States
facility: Mereo Research Site
state: Tennessee
city: Spring Hill
country: United States
facility: Mereo Research Site
state: Tennessee
city: Dallas
country: United States
facility: Mereo Research Site
state: Texas
city: Fort Worth
country: United States
facility: Mereo Research Site
state: Texas
city: Pearland
country: United States
facility: Mereo Research Site
state: Texas
city: San Antonio
country: United States
facility: Mereo Research Site
state: Texas
city: Murray
country: United States
facility: Mereo Research Site
state: Utah
city: West Jordan
country: United States
facility: Mereo Research Site
state: Utah
city: Norfolk
country: United States
facility: Mereo Research Site
state: Virginia
city: Kenosha
country: United States
facility: Mereo Research Site
state: Wisconsin
city: Ancona
country: Italy
facility: Mereo Research Site
city: Parma
country: Italy
facility: Mereo Research Site
city: Roma
country: Italy
facility: Mereo Research Site
city: Siena
country: Italy
facility: Mereo Research Site
city: Coslada
country: Spain
facility: Mereo Research Site
city: Girona
country: Spain
facility: Mereo Research Site
city: Madrid
country: Spain
facility: Mereo Research Site
city: Majadahonda
country: Spain
facility: Mereo Research Site
city: Barnsley
country: United Kingdom
facility: Mereo Research Site
city: Coventry
country: United Kingdom
facility: Mereo Research Site
city: Dundee
country: United Kingdom
facility: Mereo Research Site
city: Edinburgh
country: United Kingdom
facility: Mereo Research Site
city: Hull
country: United Kingdom
facility: Mereo Research Site
city: Manchester
country: United Kingdom
facility: Mereo Research Site
city: Newcastle
country: United Kingdom
facility: Mereo Research Site
Study officials:
affiliation: Barnsley Hospital NHS Foundation Trust
name: Hugh Jones
role: PRINCIPAL_INVESTIGATOR
References: