ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity

Zafgen

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: ZGN-440 sterile diluent; Drug: ZGN-440

Study type: Interventional

Funder types: Industry

Identifiers

NCT01507077

ZAF-101

Details and patient eligibility

About

The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).

Full description

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-440). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obese but otherwise healthy females
• Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
• BMI ≥ 30 and ≤ 45 kg/m2
• Stable body weight during the past 2 months

Exclusion criteria

• Use of weight loss agents in the past month
• History of eating disorder
• History of type 1 or type 2 diabetes mellitus
• Current smokers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

ZGN-440 sterile diluent

Placebo Comparator group

Treatment:

Drug: ZGN-440 sterile diluent

ZGN-440

Experimental group

Treatment:

Drug: ZGN-440