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

Sponsors and Collaborators:	Athersys, Inc Kendle International
Information provided by:	Athersys, Inc
ClinicalTrials.gov Identifier:	NCT00735683

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: ATHX-105 phosphate Drug: Placebo	Phase II

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity

Further study details as provided by Athersys, Inc:

Primary Outcome Measures:

Change in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

vital signs, lipids/glucose, waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	522
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo includes diet, physical activity, and lifestyle modification
2: Experimental	Drug: ATHX-105 phosphate includes diet, physical activity, and lifestyle modification
3: Experimental	Drug: ATHX-105 phosphate includes diet, physical activity, and lifestyle modification
4: Experimental	Drug: ATHX-105 phosphate includes diet, physical activity, and lifestyle modification
5: Experimental	Drug: ATHX-105 phosphate includes diet, physical activity, and lifestyle modification
6: Experimental	Drug: ATHX-105 phosphate includes diet, physical activity, and lifestyle modification

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735683

Contacts

Contact: Raymond D Starling, PhD	(216) 426-3587	rstarling@athersys.com
Contact: Matthew Celesnik	(216) 426-3585	mcelesnik@athersys.com

Sponsors and Collaborators

Athersys, Inc

Kendle International

More Information

Responsible Party:	Athersys Inc. ( Dr. John J. Harrington, Chief Scientific Officer )
Study ID Numbers:	A01-03
Study First Received:	August 13, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00735683
Health Authority:	United States: Food and Drug Administration

Keywords provided by Athersys, Inc:

Weight loss
Weight-loss drugs
Obesity
Overweight

Body weight
Diet
Metabolic Disorder
Nutrition Disorder

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Weight Loss

Nutrition Disorders
Overnutrition
Overweight
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009