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

Obesity Clinical Trial

Official title:

Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00735683
• Other study ID #: A01-03
• Status: Withdrawn
• Phase: Phase 2
• First received: August 13, 2008
• Last updated: May 29, 2015
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2015
• Source: Athersys, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• ATHX-105 phosphate
includes diet, physical activity, and lifestyle modification
• Placebo
includes diet, physical activity, and lifestyle modification

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Athersys, Inc	INC Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		12 weeks	No
Secondary	vital signs, lipids/glucose, waist circumference		12 weeks	No