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Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

Primary Purpose

Hypogonadotropic Hypogonadism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGS649
Placebo
Sponsored by
Mereo BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring Hypogonadotropic, hypogonadism, testosterone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mereo Research Site
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  • Mereo Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BGS649 0.1 mg

BGS649 0.3 mg

BGS649 1.0 mg

Placebo

Arm Description

BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)

BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)

BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)

Placebo weekly (3 indistinguishable placebo capsules)

Outcomes

Primary Outcome Measures

Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.

Secondary Outcome Measures

The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24
Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range.
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24
Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.
Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.
Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.
LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.
FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.
Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.
Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.

Full Information

First Posted
March 17, 2016
Last Updated
August 26, 2022
Sponsor
Mereo BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT02730169
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
May 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mereo BioPharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism
Keywords
Hypogonadotropic, hypogonadism, testosterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGS649 0.1 mg
Arm Type
Experimental
Arm Description
BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)
Arm Title
BGS649 0.3 mg
Arm Type
Experimental
Arm Description
BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)
Arm Title
BGS649 1.0 mg
Arm Type
Experimental
Arm Description
BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo weekly (3 indistinguishable placebo capsules)
Intervention Type
Drug
Intervention Name(s)
BGS649
Intervention Description
Capsules were taken weekly for a maximum of 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules were taken weekly for a maximum of 24 weeks
Primary Outcome Measure Information:
Title
Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
Description
Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.
Time Frame
24 weeks of treatment
Secondary Outcome Measure Information:
Title
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24
Description
Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range.
Time Frame
Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24
Description
Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.
Time Frame
Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.
Description
Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.
Time Frame
24 weeks of treatment
Title
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.
Description
LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Time Frame
Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.
Description
FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Time Frame
Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.
Description
Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.
Time Frame
Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment
Title
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.
Description
Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.
Time Frame
Week 24 and week 24/End of treatment
Other Pre-specified Outcome Measures:
Title
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.
Description
PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.
Time Frame
Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Mean (SD) Change From Baseline in Haematocrit to Week 24.
Description
Haematocrit was measured alongside other haematology parameters at screening, baseline, Visits 1 through 8 and at follow-up.
Time Frame
Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24.
Description
Summary of DEXA Scan T-score at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. DEXA T-score was calculated based on actual measured bone density value and compared to a standard reference range for healthy young adult men. A bone density scan compares bone density with the bone density expected for a young healthy adult or a healthy adult of the same age, gender and ethnicity. The difference is calculated as a standard deviation (SD) score. The measures between the bone density and the expected value of a young healthy adult is known as the T score. The World Health Organization (WHO) classifies T scores as follows: above -1 SD is normal between -1 and -2.5 SD is defined as mildly reduced bone mineral density (BMD) compared with peak bone mass (PBM) at or below -2.5 SD is defined as osteoporosis
Time Frame
Screening to Week 24
Title
Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24
Description
Summary of DEXA scan density at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. Bone density was evaluated with standard procedure for Hologic and General Electric Lunar scanners.
Time Frame
Screening to Week 24
Title
Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24.
Description
Descriptive statistics were presented for the following bone turnover marker parameters: type I collagen C-telopeptides, procollagen 1 N-terminal propeptide, osteocalcin, and bone specific alkaline phosphatase.
Time Frame
Screening to Week 24
Title
Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.
Description
Change from baseline in bone specific alkaline phosphatase at week 24 measured in U/L
Time Frame
24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Jones
Organizational Affiliation
Barnsley Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mereo Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Mereo Research Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Mereo Research Site
City
Chandler
State/Province
Arizona
Country
United States
Facility Name
Mereo Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Mereo Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Mereo Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Carlsbad
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Greenbrae
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Lincoln
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Mereo Research Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Homestead
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Mereo Research Site
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Mereo Research Site
City
Gurnee
State/Province
Illinois
Country
United States
Facility Name
Mereo Research Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Mereo Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Mereo Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Mereo Research Site
City
Elkridge
State/Province
Maryland
Country
United States
Facility Name
Mereo Research Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Mereo Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Mereo Research Site
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
Mereo Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Mereo Research Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Mereo Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Mereo Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Mereo Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Mereo Research Site
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
Mereo Research Site
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Mereo Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Mereo Research Site
City
Smyrna
State/Province
Tennessee
Country
United States
Facility Name
Mereo Research Site
City
Spring Hill
State/Province
Tennessee
Country
United States
Facility Name
Mereo Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
Pearland
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Mereo Research Site
City
Murray
State/Province
Utah
Country
United States
Facility Name
Mereo Research Site
City
West Jordan
State/Province
Utah
Country
United States
Facility Name
Mereo Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Mereo Research Site
City
Kenosha
State/Province
Wisconsin
Country
United States
Facility Name
Mereo Research Site
City
Ancona
Country
Italy
Facility Name
Mereo Research Site
City
Parma
Country
Italy
Facility Name
Mereo Research Site
City
Roma
Country
Italy
Facility Name
Mereo Research Site
City
Siena
Country
Italy
Facility Name
Mereo Research Site
City
Coslada
Country
Spain
Facility Name
Mereo Research Site
City
Girona
Country
Spain
Facility Name
Mereo Research Site
City
Madrid
Country
Spain
Facility Name
Mereo Research Site
City
Majadahonda
Country
Spain
Facility Name
Mereo Research Site
City
Barnsley
Country
United Kingdom
Facility Name
Mereo Research Site
City
Coventry
Country
United Kingdom
Facility Name
Mereo Research Site
City
Dundee
Country
United Kingdom
Facility Name
Mereo Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Mereo Research Site
City
Hull
Country
United Kingdom
Facility Name
Mereo Research Site
City
Manchester
Country
United Kingdom
Facility Name
Mereo Research Site
City
Newcastle
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

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