Phase 2
N=271
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Hypogonadotropic Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT02730169 ↗Enrolled (actual)
271
Serious AEs
5.2%
Results posted
Nov 2020
Primary outcome: Primary: Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment — 59; 62; 63; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BGS649 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Mereo BioPharma
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment |
59; 62; 63; 7 | — |
| SECONDARY The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 |
7; 12; 11; 7; 54; 53 | — |
| SECONDARY Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. |
59; 62; 63; 7 | — |
| SECONDARY Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. |
1.680; 2.095; 3.309; -0.183; 2.237; 3.626 | — |
| SECONDARY Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. |
3.553; 4.575; 5.307; -0.51; 4.158; 5.540 | — |
| SECONDARY Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. |
0.73; 2.55; 8.93; 1.43; 4.39; 14.91 | — |
| SECONDARY Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. |
0.51; 1.95; 5.81; 0.49; 1.58; 5.28 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.
Eligibility Criteria
Inclusion Criteria
- Adult male subject aged 18 to 65 years inclusive
- BMI > 30 kg/m2 and < 50 kg/m2
- Serum total testosterone concentration below the normal range
- LH levels below the upper limit of normal
- Oestradiol levels within or above the normal range of approved assay
- At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction
Exclusion Criteria
- Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
- Other types of hypogonadotropic hypogonadism or primary hypogonadism
- Any other pituitary or hypothalamic disease
Data sourced from ClinicalTrials.gov (NCT02730169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.