Hypogonadotropic Hypogonadism
Conditions
Keywords
Hypogonadotropic, hypogonadism, testosterone
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.
Interventions
DRUGBGS649
Capsules were taken weekly for a maximum of 24 weeks
DRUGPlacebo
Capsules were taken weekly for a maximum of 24 weeks
Sponsors
Mereo BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | 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. |
| The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | 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. |
| Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. | 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. | 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. |
| Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | 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. |
| Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | 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. |
| Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean (SD) Change From Baseline in Haematocrit to Week 24. | 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. |
| Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | 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 |
| Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | 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. |
| Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24. | 24 weeks | Change from baseline in bone specific alkaline phosphatase at week 24 measured in U/L |
| Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | 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. |
| Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | 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. |
Countries
Italy, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BGS649 0.1 mg BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)
BGS649: Capsules will be taken weekly for a maximum of 24 weeks | 67 |
| BGS649 0.3 mg BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)
BGS649: Capsules will be taken weekly for a maximum of 24 weeks | 66 |
| BGS649 1.0 mg BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)
BGS649: Capsules will be taken weekly for a maximum of 24 weeks | 67 |
| Placebo Placebo weekly (3 indistinguishable placebo capsules)
Placebo: Capsules will be taken weekly for a maximum of 24 weeks | 71 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 3 | 0 |
| Overall Study | Adverse Event of Special Interest | 0 | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 5 | 6 | 5 | 6 |
| Overall Study | Other | 0 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 11 | 6 | 8 |
Baseline characteristics
| Characteristic | BGS649 0.1 mg | Total | Placebo | BGS649 1.0 mg | BGS649 0.3 mg |
|---|---|---|---|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 8.39 | 50.8 years STANDARD_DEVIATION 8.69 | 50.9 years STANDARD_DEVIATION 9.17 | 49.6 years STANDARD_DEVIATION 9.72 | 51.6 years STANDARD_DEVIATION 7.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 47 Participants | 7 Participants | 15 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 53 Participants | 212 Participants | 61 Participants | 49 Participants | 49 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 67 Participants | 271 Participants | 71 Participants | 67 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 66 | 0 / 67 | 0 / 71 |
| other Total, other adverse events | 37 / 67 | 39 / 66 | 47 / 67 | 41 / 71 |
| serious Total, serious adverse events | 2 / 67 | 2 / 66 | 5 / 67 | 5 / 71 |
Outcome results
Primary
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.
Time frame: 24 weeks of treatment
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BGS649 0.1 mg | Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment | 59 Participants |
| BGS649 0.3 mg | Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment | 62 Participants |
| BGS649 1.0 mg | Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment | 63 Participants |
| Placebo | Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment | 7 Participants |
Secondary
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.
Time frame: Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment
Population: PK population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BGS649 0.1 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 5 (Week 12), 1 hour Post-Dose | 1.43 ng/mL |
| BGS649 0.1 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 5 (Week 12), Pre-Dose | 0.73 ng/mL |
| BGS649 0.1 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 8 (Week 24) | 0.85 ng/mL |
| BGS649 0.1 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 8 (Week 24)/End of Treatment | 0.78 ng/mL |
| BGS649 0.3 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 8 (Week 24)/End of Treatment | 2.76 ng/mL |
| BGS649 0.3 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 5 (Week 12), Pre-Dose | 2.55 ng/mL |
| BGS649 0.3 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 5 (Week 12), 1 hour Post-Dose | 4.39 ng/mL |
| BGS649 0.3 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 8 (Week 24) | 2.97 ng/mL |
| BGS649 1.0 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 5 (Week 12), Pre-Dose | 8.93 ng/mL |
| BGS649 1.0 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 8 (Week 24) | 10.04 ng/mL |
| BGS649 1.0 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 8 (Week 24)/End of Treatment | 9.10 ng/mL |
| BGS649 1.0 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. | Visit 5 (Week 12), 1 hour Post-Dose | 14.91 ng/mL |
Secondary
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.
Time frame: Week 24 and week 24/End of treatment
Population: PK population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BGS649 0.1 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. | Visit 8 (Week 24) | 0.51 ng/mL |
| BGS649 0.1 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. | Visit 8 (Week 24)/End of Treatment | 0.49 ng/mL |
| BGS649 0.3 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. | Visit 8 (Week 24) | 1.95 ng/mL |
| BGS649 0.3 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. | Visit 8 (Week 24)/End of Treatment | 1.58 ng/mL |
| BGS649 1.0 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. | Visit 8 (Week 24) | 5.81 ng/mL |
| BGS649 1.0 mg | Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. | Visit 8 (Week 24)/End of Treatment | 5.28 ng/mL |
Secondary
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.
Time frame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 2 (Day 8) | 3.553 mIU/mL | Standard Deviation 2.2022 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 3 (Week 4) | 4.158 mIU/mL | Standard Deviation 2.1353 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 5 (Week 12) | 4.809 mIU/mL | Standard Deviation 2.5582 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 4 (Week 8) | 4.318 mIU/mL | Standard Deviation 2.4147 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 8 (Week 24) | 4.836 mIU/mL | Standard Deviation 2.6901 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 7 (Week 20) | 5.059 mIU/mL | Standard Deviation 2.5714 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 6 (Week 16) | 5.188 mIU/mL | Standard Deviation 2.6876 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 8 (Week 24) | 6.183 mIU/mL | Standard Deviation 3.4817 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 3 (Week 4) | 5.540 mIU/mL | Standard Deviation 2.8344 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 6 (Week 16) | 6.350 mIU/mL | Standard Deviation 3.4261 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 2 (Day 8) | 4.575 mIU/mL | Standard Deviation 2.0756 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 4 (Week 8) | 5.878 mIU/mL | Standard Deviation 2.9916 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 5 (Week 12) | 5.768 mIU/mL | Standard Deviation 3.2474 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 7 (Week 20) | 6.073 mIU/mL | Standard Deviation 3.5199 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 4 (Week 8) | 7.620 mIU/mL | Standard Deviation 4.7883 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 8 (Week 24) | 8.282 mIU/mL | Standard Deviation 7.0523 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 6 (Week 16) | 8.045 mIU/mL | Standard Deviation 6.1773 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 7 (Week 20) | 8.409 mIU/mL | Standard Deviation 6.6502 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 3 (Week 4) | 6.551 mIU/mL | Standard Deviation 4.2155 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 5 (Week 12) | 8.132 mIU/mL | Standard Deviation 5.9526 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 2 (Day 8) | 5.307 mIU/mL | Standard Deviation 2.8315 |
| Placebo | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 2 (Day 8) | -0.51 mIU/mL | Standard Deviation 0.8273 |
| Placebo | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 4 (Week 8) | 0.047 mIU/mL | Standard Deviation 1.2241 |
| Placebo | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 6 (Week 16) | -0.165 mIU/mL | Standard Deviation 1.1924 |
| Placebo | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 5 (Week 12) | -0.075 mIU/mL | Standard Deviation 1.0723 |
| Placebo | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 8 (Week 24) | 0.038 mIU/mL | Standard Deviation 1.2164 |
| Placebo | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 3 (Week 4) | -0.111 mIU/mL | Standard Deviation 1.0638 |
| Placebo | Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. | Visit 7 (Week 20) | -0.030 mIU/mL | Standard Deviation 1.0932 |
Secondary
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.
Time frame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 2 (Day 8) | 1.680 mIU/mL | Standard Deviation 1.7503 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 3 (Week 4) | 2.237 mIU/mL | Standard Deviation 2.1982 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 4 (Week 8) | 2.272 mIU/mL | Standard Deviation 2.1908 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 5 (Week 12) | 2.503 mIU/mL | Standard Deviation 2.223 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 6 (Week 16) | 2.557 mIU/mL | Standard Deviation 1.6964 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 7 (Week 20) | 2.553 mIU/mL | Standard Deviation 2.238 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 8 (Week 24) | 2.108 mIU/mL | Standard Deviation 1.9892 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 3 (Week 4) | 3.626 mIU/mL | Standard Deviation 2.6519 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 4 (Week 8) | 3.653 mIU/mL | Standard Deviation 3.0907 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 5 (Week 12) | 3.511 mIU/mL | Standard Deviation 3.705 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 8 (Week 24) | 3.560 mIU/mL | Standard Deviation 3.6138 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 6 (Week 16) | 3.704 mIU/mL | Standard Deviation 3.6269 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 7 (Week 20) | 3.653 mIU/mL | Standard Deviation 3.7381 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 2 (Day 8) | 2.095 mIU/mL | Standard Deviation 1.3719 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 5 (Week 12) | 5.064 mIU/mL | Standard Deviation 3.9739 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 3 (Week 4) | 5.235 mIU/mL | Standard Deviation 4.8684 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 7 (Week 20) | 4.884 mIU/mL | Standard Deviation 3.9297 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 6 (Week 16) | 5.004 mIU/mL | Standard Deviation 4.3397 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 2 (Day 8) | 3.309 mIU/mL | Standard Deviation 1.82 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 4 (Week 8) | 5.676 mIU/mL | Standard Deviation 4.1471 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 8 (Week 24) | 5.209 mIU/mL | Standard Deviation 4.4894 |
| Placebo | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 4 (Week 8) | -0.169 mIU/mL | Standard Deviation 1.5237 |
| Placebo | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 2 (Day 8) | -0.183 mIU/mL | Standard Deviation 1.3531 |
| Placebo | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 6 (Week 16) | -0.395 mIU/mL | Standard Deviation 1.4793 |
| Placebo | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 3 (Week 4) | -0.385 mIU/mL | Standard Deviation 1.2423 |
| Placebo | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 7 (Week 20) | -0.193 mIU/mL | Standard Deviation 1.3585 |
| Placebo | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 5 (Week 12) | -0.341 mIU/mL | Standard Deviation 1.4575 |
| Placebo | Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. | Visit 8 (Week 24) | -0.043 mIU/mL | Standard Deviation 1.5575 |
Secondary
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.
Time frame: 24 weeks of treatment
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BGS649 0.1 mg | Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. | 59 Participants |
| BGS649 0.3 mg | Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. | 62 Participants |
| BGS649 1.0 mg | Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. | 63 Participants |
| Placebo | Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. | 7 Participants |
Secondary
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.
Time frame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Baseline | 0 Participants |
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 2 (Day 8) | 0 Participants |
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 3 (Week 4) | 0 Participants |
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 4 (Week 8) | 0 Participants |
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 5 (Week 12) | 0 Participants |
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 6 (Week 16) | 0 Participants |
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 7 (Week 20) | 0 Participants |
| BGS649 0.1 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 8 (Week 24) | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 8 (Week 24) | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Baseline | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 4 (Week 8) | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 2 (Day 8) | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 7 (Week 20) | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 5 (Week 12) | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 6 (Week 16) | 0 Participants |
| BGS649 0.3 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 3 (Week 4) | 0 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 5 (Week 12) | 2 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 7 (Week 20) | 0 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Baseline | 0 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 8 (Week 24) | 1 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 4 (Week 8) | 1 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 6 (Week 16) | 2 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 2 (Day 8) | 0 Participants |
| BGS649 1.0 mg | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 3 (Week 4) | 0 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 2 (Day 8) | 0 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 3 (Week 4) | 0 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 4 (Week 8) | 0 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 6 (Week 16) | 1 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 7 (Week 20) | 1 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Baseline | 0 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 5 (Week 12) | 2 Participants |
| Placebo | Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 | Visit 8 (Week 24) | 0 Participants |
Secondary
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.
Time frame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 2 (Day 8) | 54 Participants |
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 7 (Week 20) | 57 Participants |
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 4 (Week 8) | 63 Participants |
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Baseline | 7 Participants |
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 8 (Week 24) | 59 Participants |
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 5 (Week 12) | 58 Participants |
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 3 (Week 4) | 63 Participants |
| BGS649 0.1 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 6 (Week 16) | 57 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 2 (Day 8) | 53 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 6 (Week 16) | 63 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Baseline | 12 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 3 (Week 4) | 62 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 8 (Week 24) | 62 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 4 (Week 8) | 61 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 5 (Week 12) | 62 Participants |
| BGS649 0.3 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 7 (Week 20) | 63 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Baseline | 11 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 2 (Day 8) | 57 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 3 (Week 4) | 64 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 5 (Week 12) | 64 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 6 (Week 16) | 63 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 7 (Week 20) | 66 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 8 (Week 24) | 63 Participants |
| BGS649 1.0 mg | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 4 (Week 8) | 65 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 7 (Week 20) | 9 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 4 (Week 8) | 11 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 3 (Week 4) | 10 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Baseline | 7 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 8 (Week 24) | 7 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 6 (Week 16) | 8 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 5 (Week 12) | 7 Participants |
| Placebo | The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 | Visit 2 (Day 8) | 7 Participants |
Other Pre-specified
Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.
Change from baseline in bone specific alkaline phosphatase at week 24 measured in U/L
Time frame: 24 weeks
Population: ITT population on all available samples and including all wk 24 and end-of-treatment visit data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BGS649 0.1 mg | Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24. | 0.15 U/L | Standard Deviation 3.187 |
| BGS649 0.3 mg | Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24. | 0.69 U/L | Standard Deviation 4.556 |
| BGS649 1.0 mg | Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24. | 0.03 U/L | Standard Deviation 3.629 |
| Placebo | Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24. | 0.29 U/L | Standard Deviation 3.197 |
Other Pre-specified
Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at 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.
Time frame: Screening to Week 24
Population: ITT Population. Discrepancies in numbers from the progress flow are due to missing samples either at baseline or wk 24/EOT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Osteocalcin | 0.72 ug/L | Standard Deviation 2.891 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Type I Collagen C-Telopeptides | 0.054 ug/L | Standard Deviation 0.1454 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Procollagen 1 N-Terminal Propeptide | 5.2 ug/L | Standard Deviation 8.31 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Osteocalcin | 0.35 ug/L | Standard Deviation 3.801 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Type I Collagen C-Telopeptides | 0.069 ug/L | Standard Deviation 0.1618 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Procollagen 1 N-Terminal Propeptide | 5.0 ug/L | Standard Deviation 11.93 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Type I Collagen C-Telopeptides | 0.047 ug/L | Standard Deviation 0.1342 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Procollagen 1 N-Terminal Propeptide | 4.3 ug/L | Standard Deviation 11.68 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Osteocalcin | 0.36 ug/L | Standard Deviation 3.604 |
| Placebo | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Type I Collagen C-Telopeptides | 0.020 ug/L | Standard Deviation 0.2087 |
| Placebo | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Osteocalcin | 0.30 ug/L | Standard Deviation 3.267 |
| Placebo | Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. | Procollagen 1 N-Terminal Propeptide | 1.8 ug/L | Standard Deviation 11.61 |
Other Pre-specified
Mean (SD) Change From Baseline in DEXA Scan Density by Location at 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.
Time frame: Screening to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BGS649 0.1 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Hip | -0.0026 g/cm^2 | Standard Deviation 0.0399 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Lumber spine | -0.0167 g/cm^2 | Standard Deviation 0.03174 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Femoral neck | -0.0248 g/cm^2 | Standard Deviation 0.04583 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Hip | -0.0020 g/cm^2 | Standard Deviation 0.03828 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Lumber spine | -0.0177 g/cm^2 | Standard Deviation 0.05018 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Femoral neck | -0.0044 g/cm^2 | Standard Deviation 0.06666 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Femoral neck | -0.0116 g/cm^2 | Standard Deviation 0.05139 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Hip | -0.0072 g/cm^2 | Standard Deviation 0.02724 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Lumber spine | -0.0255 g/cm^2 | Standard Deviation 0.04044 |
| Placebo | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Hip | 0.0005 g/cm^2 | Standard Deviation 0.03315 |
| Placebo | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Lumber spine | 0.0100 g/cm^2 | Standard Deviation 0.04016 |
| Placebo | Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 | Femoral neck | 0.0028 g/cm^2 | Standard Deviation 0.02747 |
Other Pre-specified
Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at 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
Time frame: Screening to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Lumber spine | -0.12 T-score | Standard Deviation 0.279 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Femoral neck | -0.16 T-score | Standard Deviation 0.337 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Hip | 0.01 T-score | Standard Deviation 0.382 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Hip | 0.05 T-score | Standard Deviation 0.315 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Femoral neck | 0.02 T-score | Standard Deviation 0.441 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Lumber spine | -0.08 T-score | Standard Deviation 0.381 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Lumber spine | -0.22 T-score | Standard Deviation 0.351 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Hip | -0.02 T-score | Standard Deviation 0.323 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Femoral neck | -0.11 T-score | Standard Deviation 0.392 |
| Placebo | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Hip | 0.01 T-score | Standard Deviation 0.266 |
| Placebo | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Femoral neck | 0.03 T-score | Standard Deviation 0.212 |
| Placebo | Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. | Lumber spine | 0.07 T-score | Standard Deviation 0.346 |
Other Pre-specified
Mean (SD) Change From Baseline in Haematocrit to Week 24.
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
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 5 (Week 12) | 0.0153 Ratio | Standard Deviation 0.02419 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 6 (Week 16) | 0.0142 Ratio | Standard Deviation 0.02195 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 7 (Week 20) | 0.0195 Ratio | Standard Deviation 0.02545 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 4 (Week 8) | 0.0151 Ratio | Standard Deviation 0.02153 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 8 (Week 24) | 0.0171 Ratio | Standard Deviation 0.02612 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 2 (Day 8) | -0.0003 Ratio | Standard Deviation 0.02279 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 3 (Week 4) | 0.0036 Ratio | Standard Deviation 0.01855 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 3 (Week 4) | 0.0024 Ratio | Standard Deviation 0.02095 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 7 (Week 20) | 0.0192 Ratio | Standard Deviation 0.02672 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 8 (Week 24) | 0.0159 Ratio | Standard Deviation 0.02621 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 4 (Week 8) | 0.0162 Ratio | Standard Deviation 0.02709 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 5 (Week 12) | 0.0175 Ratio | Standard Deviation 0.0227 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 6 (Week 16) | 0.0233 Ratio | Standard Deviation 0.02408 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 2 (Day 8) | 0.0014 Ratio | Standard Deviation 0.01945 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 6 (Week 16) | 0.0229 Ratio | Standard Deviation 0.0326 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 5 (Week 12) | 0.0256 Ratio | Standard Deviation 0.02906 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 7 (Week 20) | 0.0187 Ratio | Standard Deviation 0.03222 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 2 (Day 8) | -0.0016 Ratio | Standard Deviation 0.03487 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 4 (Week 8) | 0.0258 Ratio | Standard Deviation 0.03233 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 3 (Week 4) | 0.0067 Ratio | Standard Deviation 0.02997 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 8 (Week 24) | 0.0216 Ratio | Standard Deviation 0.02587 |
| Placebo | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 6 (Week 16) | -0.0079 Ratio | Standard Deviation 0.02533 |
| Placebo | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 3 (Week 4) | -0.0024 Ratio | Standard Deviation 0.02539 |
| Placebo | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 4 (Week 8) | -0.0041 Ratio | Standard Deviation 0.02383 |
| Placebo | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 7 (Week 20) | -0.0063 Ratio | Standard Deviation 0.03037 |
| Placebo | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 8 (Week 24) | -0.0032 Ratio | Standard Deviation 0.02884 |
| Placebo | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 2 (Day 8) | -0.0029 Ratio | Standard Deviation 0.02374 |
| Placebo | Mean (SD) Change From Baseline in Haematocrit to Week 24. | Visit 5 (Week 12) | -0.0082 Ratio | Standard Deviation 0.02882 |
Other Pre-specified
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.
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
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 5 (Week 12) | 0.190 ug/L | Standard Deviation 0.3895 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 2 (Day 8) | 0.045 ug/L | Standard Deviation 0.184 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 8 (Week 24) | 0.218 ug/L | Standard Deviation 0.4312 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 7 (Week 20) | 0.158 ug/L | Standard Deviation 0.2913 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 6 (Week 16) | 0.147 ug/L | Standard Deviation 0.2655 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 4 (Week 8) | 0.166 ug/L | Standard Deviation 0.2651 |
| BGS649 0.1 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 3 (Week 4) | 0.141 ug/L | Standard Deviation 0.1742 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 7 (Week 20) | 0.480 ug/L | Standard Deviation 2.6029 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 3 (Week 4) | 0.082 ug/L | Standard Deviation 0.5198 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 4 (Week 8) | 0.105 ug/L | Standard Deviation 0.4747 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 8 (Week 24) | 0.391 ug/L | Standard Deviation 1.8627 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 2 (Day 8) | 0.040 ug/L | Standard Deviation 0.483 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 5 (Week 12) | 0.271 ug/L | Standard Deviation 0.9626 |
| BGS649 0.3 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 6 (Week 16) | 0.102 ug/L | Standard Deviation 0.55 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 4 (Week 8) | 0.132 ug/L | Standard Deviation 0.3343 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 2 (Day 8) | 0.011 ug/L | Standard Deviation 0.4606 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 7 (Week 20) | 0.116 ug/L | Standard Deviation 0.456 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 6 (Week 16) | 0.160 ug/L | Standard Deviation 0.4037 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 8 (Week 24) | 0.085 ug/L | Standard Deviation 0.293 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 3 (Week 4) | 0.092 ug/L | Standard Deviation 0.4338 |
| BGS649 1.0 mg | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 5 (Week 12) | 0.178 ug/L | Standard Deviation 0.5405 |
| Placebo | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 7 (Week 20) | 0.022 ug/L | Standard Deviation 0.3942 |
| Placebo | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 4 (Week 8) | 0.055 ug/L | Standard Deviation 0.45 |
| Placebo | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 5 (Week 12) | 0.039 ug/L | Standard Deviation 0.4382 |
| Placebo | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 3 (Week 4) | 0.038 ug/L | Standard Deviation 0.27 |
| Placebo | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 2 (Day 8) | 0.015 ug/L | Standard Deviation 0.2179 |
| Placebo | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 8 (Week 24) | 0.067 ug/L | Standard Deviation 0.4787 |
| Placebo | Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. | Visit 6 (Week 16) | 0.016 ug/L | Standard Deviation 0.2631 |