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

Mereo BioPharma

Status and phase: Completed; Phase 2

Conditions: Hypogonadotropic Hypogonadism

Treatments: Drug: BGS649; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02730169

MBGS205

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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271 participants in 4 patient groups, including a placebo group

BGS649 0.1 mg

Experimental group

Description:

BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)

Treatment:

Drug: BGS649

BGS649 0.3 mg

Experimental group

Description:

BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)

Treatment:

Drug: BGS649

BGS649 1.0 mg

Experimental group

Description:

BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)

Treatment:

Drug: BGS649

Placebo

Placebo Comparator group

Description:

Placebo weekly (3 indistinguishable placebo capsules)

Treatment:

Drug: Placebo