A Short-Term Study to Examine the Effects of ATHX-105 Pho... | NCT00735683

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

NCT00735683

Sponsor

Healios K.K.

Status

Withdrawn

Last Update Posted

Jun 2, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Obesity

Interventions

ATHX-105 phosphate
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Apr 2009Estimated

Completion Date

Apr 2009Estimated

First Submitted Date

Aug 13, 2008

First Submission Date that Met QC Criteria

Aug 14, 2008

First Posted Date

Aug 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2015

Last Update Posted Date

Jun 2, 2015Estimated

Name	Class
Syneos Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Placebo Comparator	Drug: Placebo
2	Experimental	Drug: ATHX-105 phosphate
3	Experimental	Drug: ATHX-105 phosphate
4	Experimental	Drug: ATHX-105 phosphate
5	Experimental	Drug: ATHX-105 phosphate
6	Experimental	Drug: ATHX-105 phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATHX-105 phosphate	Drug	includes diet, physical activity, and lifestyle modification	2 3 4 5 6

Measure	Description	Time Frame
Change in body weight		12 weeks

Measure	Description	Time Frame
vital signs, lipids/glucose, waist circumference		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss
D050177	Overweight
D001835	Body Weight
D008659	Metabolic Diseases
D009748	Nutrition Disorders

Ancestor Terms

ID	Term
D044343	Overnutrition
D009750	Nutritional and Metabolic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided