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

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ClinicalTrials.gov Identifier: NCT00735683
Recruitment Status : Withdrawn
First Posted : August 15, 2008
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
INC Research
Information provided by:
Athersys, Inc

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

Condition or disease Intervention/treatment Phase
Obesity Drug: ATHX-105 phosphate Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity
Study Start Date : September 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
includes diet, physical activity, and lifestyle modification
Experimental: 2 Drug: ATHX-105 phosphate
includes diet, physical activity, and lifestyle modification
Experimental: 3 Drug: ATHX-105 phosphate
includes diet, physical activity, and lifestyle modification
Experimental: 4 Drug: ATHX-105 phosphate
includes diet, physical activity, and lifestyle modification
Experimental: 5 Drug: ATHX-105 phosphate
includes diet, physical activity, and lifestyle modification
Experimental: 6 Drug: ATHX-105 phosphate
includes diet, physical activity, and lifestyle modification



Primary Outcome Measures :
  1. Change in body weight [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. vital signs, lipids/glucose, waist circumference [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Dr. John J. Harrington, Chief Scientific Officer, Athersys Inc.
ClinicalTrials.gov Identifier: NCT00735683     History of Changes
Other Study ID Numbers: A01-03
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015

Keywords provided by Athersys, Inc:
Weight loss
Weight-loss drugs
Obesity
Overweight
Body weight
Diet
Metabolic Disorder
Nutrition Disorder

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes