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

• Status: Completed
• Trial end date: 2018-05-19
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mereo BioPharma

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