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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Withdrawn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
Athersys, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 13, 2008
    Last Updated
    May 29, 2015
    Sponsor
    Athersys, Inc
    Collaborators
    Syneos Health
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    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    Withdrawn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

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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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