An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome

Zafgen

Status and phase: Completed; Phase 2

Conditions: Over-weight; Prader-Willi Syndrome; Obesity

Treatments: Drug: ZGN-440 sterile diluent; Drug: 1.8 mg ZGN-440 for injectable suspension; Drug: 1.2 mg ZGN-440 for injectable suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01818921

ZAF-211

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.

Enrollment: 17 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
• BMI ≥25 kg/m2
• Type 2 diabetes mellitus is allowed
• Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
• Stable body weight during the past 3 months, except for during home visits

Exclusion criteria

• Use of weight loss agents in the past 3 months
• Type 1 diabetes mellitus
• Current or anticipated chronic use of narcotics or opiates

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups, including a placebo group

ZGN-440 sterile diluent

Placebo Comparator group

Description:

Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks.

Treatment:

Drug: ZGN-440 sterile diluent

1.2 mg ZGN-440 for injectable suspension

Experimental group

Description:

Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Treatment:

Drug: 1.2 mg ZGN-440 for injectable suspension

1.8 mg ZGN-440 for injectable suspension

Experimental group

Description:

Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Treatment:

Drug: 1.8 mg ZGN-440 for injectable suspension