A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety
Primary Purpose
Obesity
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ATHX-105 phosphate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight loss, Weight-loss drugs, Obesity, Overweight, Body weight, Diet, Metabolic Disorder, Nutrition Disorder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
Arm Description
Outcomes
Primary Outcome Measures
Change in body weight
Secondary Outcome Measures
vital signs, lipids/glucose, waist circumference
Full Information
NCT ID
NCT00735683
First Posted
August 13, 2008
Last Updated
May 29, 2015
Sponsor
Athersys, Inc
Collaborators
Syneos Health
1. Study Identification
Unique Protocol Identification Number
NCT00735683
Brief Title
A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Athersys, Inc
Collaborators
Syneos Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss, Weight-loss drugs, Obesity, Overweight, Body weight, Diet, Metabolic Disorder, Nutrition Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ATHX-105 phosphate
Intervention Description
includes diet, physical activity, and lifestyle modification
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
includes diet, physical activity, and lifestyle modification
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
vital signs, lipids/glucose, waist circumference
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety
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