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

NCT ID: NCT00735683

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

includes diet, physical activity, and lifestyle modification

2

Group Type EXPERIMENTAL

ATHX-105 phosphate

Intervention Type DRUG

includes diet, physical activity, and lifestyle modification

3

Group Type EXPERIMENTAL

ATHX-105 phosphate

Intervention Type DRUG

includes diet, physical activity, and lifestyle modification

4

Group Type EXPERIMENTAL

ATHX-105 phosphate

Intervention Type DRUG

includes diet, physical activity, and lifestyle modification

5

Group Type EXPERIMENTAL

ATHX-105 phosphate

Intervention Type DRUG

includes diet, physical activity, and lifestyle modification

6

Group Type EXPERIMENTAL

ATHX-105 phosphate

Intervention Type DRUG

includes diet, physical activity, and lifestyle modification

Interventions

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ATHX-105 phosphate

includes diet, physical activity, and lifestyle modification

Intervention Type DRUG

Placebo

includes diet, physical activity, and lifestyle modification

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

Healios K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Athersys Inc.

Other Identifiers

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A01-03

Identifier Type: -

Identifier Source: org_study_id

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