Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

Zafgen

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Normal Saline; Drug: ZGN-433

Study type: Interventional

Funder types: Industry

Identifiers

NCT01372761

ZAF-003AUS

Details and patient eligibility

About

The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

Full description

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). 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-433 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 ≤ 50 kg/m2
• Stable body weight during the past month

Exclusion criteria

• Use of weight loss agents in the past month
• History of eating disorder
• History of gastric bypass surgery
• 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

Normal Saline

Placebo Comparator group

Treatment:

Drug: Normal Saline

ZGN-433

Experimental group

Treatment:

Drug: ZGN-433