ObesityPhase 2NCT00735683
A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety
A Phase 2 study testing ATHX-105 phosphate in people with Obesity, run by Healios K.K..
Trial summary
This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- ATHX-105 phosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese adults with a body mass index of 30-45 kg/m2
Who cannot join
- Pregnancy
- Diabetes
- Adults with serious or unstable current or past medical conditions
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity
This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.
Read the 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.
- Conditions
- Obesity
- Being tested
- ATHX-105 phosphate, Placebo
- Keywords
- Weight loss, Weight-loss drugs, Obesity, Overweight, Body weight, Diet, Metabolic Disorder, Nutrition Disorder
- Medical subject headings
- Obesity, Weight Loss, Overweight, Body Weight, Metabolic Diseases, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATHX-105 phosphateDrug
includes diet, physical activity, and lifestyle modification
PlaceboDrug
includes diet, physical activity, and lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: ATHX-105 phosphate |
| 3 | Experimental | Not described Receives: Drug: ATHX-105 phosphate |
| 4 | Experimental | Not described Receives: Drug: ATHX-105 phosphate |
| 5 | Experimental | Not described Receives: Drug: ATHX-105 phosphate |
| 6 | Experimental | Not described Receives: Drug: ATHX-105 phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: 12 weeks
Secondary outcomes (1)
vital signs, lipids/glucose, waist circumference
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healios K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735683
- Sponsor's protocol ID
- A01-03
- Status last verified
- May 2015
- First submitted
- 13 Aug 2008
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT00735683
- Acronym / sponsor ID
- A01-03
- Conditions
- Obesity
- Keywords
- Weight loss, Weight-loss drugs, Obesity, Overweight, Body weight, Diet, Metabolic Disorder, Nutrition Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Healios K.K.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese adults with a body mass index of 30-45 kg/m2
Key exclusion criteria (3 listed)
- Pregnancy
- Diabetes
- Adults with serious or unstable current or past medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATHX-105 phosphateincludes diet, physical activity, and lifestyle modification | Drug | 2, 3, 4, 5, 6 |
| Placeboincludes diet, physical activity, and lifestyle modification | Drug | 1 |
Primary outcome
Change in body weight
Time frame: 12 weeks
1 secondary outcome
vital signs, lipids/glucose, waist circumference
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATHX-105 phosphate in people with Obesity, run by Healios K.K..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.