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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
INC Research
Information provided by:
Athersys, Inc
ClinicalTrials.gov Identifier:
NCT00735683
First received: August 13, 2008
Last updated: June 6, 2011
Last verified: June 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. John J. Harrington, Chief Scientific Officer, Athersys Inc.
ClinicalTrials.gov Identifier: NCT00735683     History of Changes
Other Study ID Numbers: A01-03
Study First Received: August 13, 2008
Last Updated: June 6, 2011
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

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

ClinicalTrials.gov processed this record on July 29, 2014