An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects

Zafgen

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Beloranib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01666691

ZAF-201

Details and patient eligibility

About

The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.

Full description

This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. 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: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obese volunteers weighing ≥ 50 kg
• BMI ≥ 30 and ≤ 50 kg/m2
• Stable body weight during the past 2 months
• Type 2 diabetes mellitus is allowed

Exclusion criteria

• Use of weight loss agents in the past month
• Current, clinically significant eating disorder
• Type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

160 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

ZGN-440 sterile diluent

Treatment:

Drug: Placebo

0.3 mg Beloranib

Experimental group

Description:

0.3 mg ZGN-440 for injectable suspension

Treatment:

Drug: Beloranib

0.6 mg Beloranib

Experimental group

Description:

0.6 mg ZGN-440 for injectable suspension

Treatment:

Drug: Beloranib

1.2 mg Beloranib

Experimental group

Description:

1.2 mg ZGN-440 for injectable suspension

Treatment:

Drug: Beloranib

2.4 mg Beloranib

Experimental group

Description:

2.4 mg ZGN-440 for injectable suspension

Treatment:

Drug: Beloranib

3.2 mg Beloranib

Experimental group

Description:

3.2 mg ZGN-440 for injectable suspension

Treatment:

Drug: Beloranib