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Completed

NCT Number: NCT02730169

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.

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Key information

Conditions

Hypogonadotropic Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mereo Research Site, Ancona, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGS649

Drug

Capsules were taken weekly for a maximum of 24 weeks

Placebo

Drug

Capsules were taken weekly for a maximum of 24 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Mereo BioPharma

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2016
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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