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

Zafgen

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: ZGN-433

Study type: Interventional

Funder types: Industry

Identifiers

NCT01028261

ZAF-001

Details and patient eligibility

About

The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

Full description

This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obese, otherwise healthy females
• Post menopausal or infertile
• Weight ≥ 50 kg
• BMI ≥ 32 and ≤ 45 kg/m2

Exclusion criteria

• Use of weight loss agents in the past month
• History of eating disorder
• History of diabetes or other endocrine disorder
• History of gastric bypass
• Current smokers
• Unstable body weight during the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

ZGN-433

Experimental group

Treatment:

Drug: ZGN-433

Normal Saline

Placebo Comparator group

Treatment:

Drug: ZGN-433