A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety

Phase 2

Withdrawn

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: ATHX-105 phosphate

• Registration Number: NCT00735683
• Lead Sponsor: Healios K.K.

Brief Summary

This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.

Detailed Description

The rate of obesity in adults continues to increase. Obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. To date, the medication options to treat obesity have been limited.

This study will examine if a new investigational drug, ATHX-105 phosphate, may cause weight loss in humans over a 12-week period.

Study Timeline

• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Study Start: 2008-09
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Obese adults with a body mass index of 30-45 kg/m2

Exclusion Criteria

• Pregnancy
• Diabetes
• Adults with serious or unstable current or past medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	ATHX-105 phosphate	-
3	ATHX-105 phosphate	-
4	ATHX-105 phosphate	-
5	ATHX-105 phosphate	-
6	ATHX-105 phosphate	-

Primary Outcome Measures

Name	Time	Method
Change in body weight	12 weeks

Secondary Outcome Measures

Name	Time	Method
vital signs, lipids/glucose, waist circumference	12 weeks