NCT00735683

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2 obesity

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

August 13, 2008

Last Update Submit

May 29, 2015

Conditions

Obesity

Keywords

Weight lossWeight-loss drugsObesityOverweightBody weightDietMetabolic DisorderNutrition Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    12 weeks

Secondary Outcomes (1)

  • vital signs, lipids/glucose, waist circumference

    12 weeks

Study Arms (6)

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

ATHX-105 phosphateDRUG

includes diet, physical activity, and lifestyle modification

23456
PlaceboDRUG

includes diet, physical activity, and lifestyle modification

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese adults with a body mass index of 30-45 kg/m2

You may not qualify if:

  • Pregnancy
  • Diabetes
  • Adults with serious or unstable current or past medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight LossOverweightBody WeightMetabolic DiseasesNutrition Disorders

Condition Hierarchy (Ancestors)

OvernutritionNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 2, 2015

Record last verified: 2015-05