An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

Zafgen

Status and phase: Completed; Phase 2

Conditions: Over-weight; Hypothalamic Injury; Obesity; Craniopharyngioma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063295

ZAF-221

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
• Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
• Stable body weight for at least 3 months
• Type 2 diabetes mellitus is allowed

Exclusion criteria

• Males taking gonadotropin replacement therapy (LH/FSH)
• Subjects who are planning any fertility treatment within 6 months of study participation
• Use of weight loss agents, including herbal medications, in the past 3 months
• Current or anticipated chronic use of narcotics or opiates
• History of severe psychiatric disorders
• Type 1 diabetes mellitus
• Metabolic disorders or genetic disorders linked to obesity
• History of any bariatric surgery
• Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
• Blood loss or donation >500 mL within the past 3 months
• Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14 participants in 2 patient groups, including a placebo group

ZGN-440 sterile diluent

Placebo Comparator group

Description:

Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.

Treatment:

Drug: ZGN-440 sterile diluent

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: ZGN-440 for injectable suspension