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

August 26, 2022 updated by: Mereo BioPharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Mereo Research Site
      • Parma, Italy
        • Mereo Research Site
      • Roma, Italy
        • Mereo Research Site
      • Siena, Italy
        • Mereo Research Site
  • Spain
      • Coslada, Spain
        • Mereo Research Site
      • Girona, Spain
        • Mereo Research Site
      • Madrid, Spain
        • Mereo Research Site
      • Majadahonda, Spain
        • Mereo Research Site
  • United Kingdom
      • Barnsley, United Kingdom
        • Mereo Research Site
      • Coventry, United Kingdom
        • Mereo Research Site
      • Dundee, United Kingdom
        • Mereo Research Site
      • Edinburgh, United Kingdom
        • Mereo Research Site
      • Hull, United Kingdom
        • Mereo Research Site
      • Manchester, United Kingdom
        • Mereo Research Site
      • Newcastle, United Kingdom
        • Mereo Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Mereo Research Site
      • Mobile, Alabama, United States
        • Mereo Research Site
    • Arizona
      • Chandler, Arizona, United States
        • Mereo Research Site
      • Phoenix, Arizona, United States
        • Mereo Research Site
      • Scottsdale, Arizona, United States
        • Mereo Research Site
    • California
      • Anaheim, California, United States
        • Mereo Research Site
      • Carlsbad, California, United States
        • Mereo Research Site
      • Greenbrae, California, United States
        • Mereo Research Site
      • Lincoln, California, United States
        • Mereo Research Site
      • Los Angeles, California, United States
        • Mereo Research Site
      • San Diego, California, United States
        • Mereo Research Site
    • Florida
      • Bradenton, Florida, United States
        • Mereo Research Site
      • DeLand, Florida, United States
        • Mereo Research Site
      • Fort Myers, Florida, United States
        • Mereo Research Site
      • Hialeah, Florida, United States
        • Mereo Research Site
      • Homestead, Florida, United States
        • Mereo Research Site
      • Saint Petersburg, Florida, United States
        • Mereo Research Site
    • Idaho
      • Meridian, Idaho, United States
        • Mereo Research Site
    • Illinois
      • Gurnee, Illinois, United States
        • Mereo Research Site
    • Indiana
      • Evansville, Indiana, United States
        • Mereo Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Mereo Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Mereo Research Site
      • Elkridge, Maryland, United States
        • Mereo Research Site
    • Missouri
      • Saint Louis, Missouri, United States
        • Mereo Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Mereo Research Site
    • Nevada
      • Henderson, Nevada, United States
        • Mereo Research Site
      • Las Vegas, Nevada, United States
        • Mereo Research Site
    • New York
      • Albany, New York, United States
        • Mereo Research Site
      • Garden City, New York, United States
        • Mereo Research Site
      • Great Neck, New York, United States
        • Mereo Research Site
      • New York, New York, United States
        • Mereo Research Site
      • Rochester, New York, United States
        • Mereo Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Mereo Research Site
      • Raleigh, North Carolina, United States
        • Mereo Research Site
      • Winston-Salem, North Carolina, United States
        • Mereo Research Site
    • Ohio
      • Middleburg Heights, Ohio, United States
        • Mereo Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States
        • Mereo Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Mereo Research Site
      • Smyrna, Tennessee, United States
        • Mereo Research Site
      • Spring Hill, Tennessee, United States
        • Mereo Research Site
    • Texas
      • Dallas, Texas, United States
        • Mereo Research Site
      • Fort Worth, Texas, United States
        • Mereo Research Site
      • Pearland, Texas, United States
        • Mereo Research Site
      • San Antonio, Texas, United States
        • Mereo Research Site
    • Utah
      • Murray, Utah, United States
        • Mereo Research Site
      • West Jordan, Utah, United States
        • Mereo Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Mereo Research Site
    • Wisconsin
      • Kenosha, Wisconsin, United States
        • Mereo Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BGS649 0.1 mg
BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)
Drug: BGS649
Capsules were taken weekly for a maximum of 24 weeks
Experimental: BGS649 0.3 mg
BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)
Drug: BGS649
Capsules were taken weekly for a maximum of 24 weeks
Experimental: BGS649 1.0 mg
BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)
Drug: BGS649
Capsules were taken weekly for a maximum of 24 weeks
Placebo Comparator: Placebo
Placebo weekly (3 indistinguishable placebo capsules)
Drug: Placebo
Capsules were taken weekly for a maximum of 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
Time Frame: 24 weeks of 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.
24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24
Time Frame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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.
Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24
Time Frame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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.
Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.
Time Frame: 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.
24 weeks of treatment
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.
Time Frame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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.
Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.
Time Frame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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.
Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.
Time Frame: Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment
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.
Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.
Time Frame: Week 24 and week 24/End of treatment
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.
Week 24 and week 24/End of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.
Time Frame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.
Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Mean (SD) Change From Baseline in Haematocrit to Week 24.
Time Frame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Haematocrit was measured alongside other haematology parameters at screening, baseline, Visits 1 through 8 and at follow-up.
Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24.
Time Frame: Screening to Week 24

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
Screening to Week 24
Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24
Time Frame: Screening to Week 24
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.
Screening to Week 24
Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24.
Time Frame: Screening to Week 24
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.
Screening to Week 24
Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.
Time Frame: 24 weeks
Change from baseline in bone specific alkaline phosphatase at week 24 measured in U/L
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mereo BioPharma

Investigators

  • Principal Investigator: Hugh Jones, Barnsley Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2016

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

May 19, 2018

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBGS205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypogonadotropic Hypogonadism

Clinical Trials on BGS649

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe