SchizophreniaPhase 3NCT00401973

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

A Phase 3 study testing olanzapine, amantadine and metformin in people with Schizophrenia and Schizoaffective Disorders, run by Eli Lilly and Company at 15 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this study is to answer the following questions: Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorders
What is being tested?: olanzapine, amantadine and metformin
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 15 sitesin 7 countries
Study dates: Nov 2006to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

You must have been diagnosed with schizophrenia or schizoaffective disorder
You must be able to visit the doctor's office once every two weeks for three months, then once every four weeks for the next three months with a possible bi-weekly visit during the fifth month
If you are currently taking a medication for schizophrenia or schizoaffective disorder, you have been taking it for at least 30 days without any changes
If you are a female, you must have a negative pregnancy test and be using an effective method of contraception

Who cannot join

You have a diagnosis of bipolar I disorder, diabetes, very high triglyceride level (fasting triglycerides greater than or equal to 500 mg/dL), recent heart attack, stroke, uncontrolled seizures, serious infection, unstable heart disease (such as ischemic heart disease or congestive heart failure), an uncorrected narrow angle glaucoma or human immunodeficiency virus (HIV)
You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood
You have a diagnosis of an eating disorder
You have a history of Parkinson's Disease or any related disorders
You are allergic to sulfa drugs or any of the medications involved in this study

Trial locations and contacts

15 sites in 7 countries.

Country

City, postcode or hospital

15 sites in 7 countries

United States5 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Canton, Ohio, 44708
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
DeSoto, Texas, 75115
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Johnson City, Tennessee, 37614
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, 38105
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
National City, California, 91950

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Puerto Rico4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bayamón, 00961
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ponce, 00717
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Juan, 00907
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Juan

Other trials in Puerto Rico

Brazil2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rio de Janeiro, 21020-130
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Salvador, 40301500

Other trials in Brazil

Israel1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beer Yaacov, 70350

Other trials in Israel

Mexico1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, 14050

Other trials in Mexico

Russia1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Moscow, 117603

Other trials in Russia

South Korea1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, 143-711

Other trials in South Korea

About this study

Official title: The Assessment of the Safety, Efficacy, and Practicality of an Algorithm Including Amantadine, Metformin and Zonisamide for the Prevention of Olanzapine-Associated Weight Gain in Outpatients With Schizophrenia

The goal of this study is to answer the following questions:

Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine
Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain
How weight gain associated with olanzapine can affect people
Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases

Conditions: Schizophrenia, Schizoaffective Disorders
Being tested: olanzapine, amantadine, metformin, zonisamide, Wellness education
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

olanzapineDrug
Also called LY170053, Zyprexa
5-20 milligrams (mg), oral, daily for 22 weeks.
amantadineDrug
Amantadine, 100 milligrams (mg), oral, 1 twice a day (BID). Patients who gained greater than 3 kilograms (kg) will switch to metformin. Patients who gained greater than 3 kg after switching to metformin will be switched to zonisamide.
metforminDrug
Metformin, 500 mg, oral, twice a day (BID) for 2 weeks titrated to 500mg three times a day (TID) thereafter. Patients who gain greater than 3 kilograms (kg) will be switched to amantadine. Patients who gained greater than 3 kg after switching to amantadine will be switched to zonisamide.
zonisamideDrug
Zonisamide, 100-400mg, oral, daily.
Wellness educationBehavioural
weight management

Study groups in NCT00401973
Study group	Role	What they receive
Olanzapine	Experimental	olanzapine plus behavioral information Receives: Drug: olanzapine; Behavioral: Wellness education
Olanzapine + Amantadine	Experimental	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information Receives: Drug: olanzapine; Drug: amantadine; Drug: metformin; Drug: zonisamide; Behavioral: Wellness education
Olanzapine + Metformin	Experimental	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information Receives: Drug: olanzapine; Drug: amantadine; Drug: metformin; Drug: zonisamide; Behavioral: Wellness education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Endpoint in Weight
Measured: Baseline to endpoint (22 weeks)

Secondary outcomes (10)

Mean Change From Baseline to Endpoint in Fasting Triglycerides
Measured: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Total Cholesterol
Measured: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol
Measured: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol
Measured: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Glucose
Measured: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Hemoglobin A1c
Measured: Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score
The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.
Measured: Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Measured: Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Baseline to endpoint (22 weeks)
Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks
To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.
Measured: Baseline to endpoint (22 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Sep 2008

First posted22 Nov 2006 (estimated)
Study startNov 2006
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00401973
Sponsor's protocol ID: 10768
Other IDs: F1D-US-HGMM
Status last verified: Sep 2009
First submitted: 17 Nov 2006
Last updated: 6 Oct 2009
Results posted: Yes, on ClinicalTrials.gov

Publications

Hoffmann VP, Case M, Jacobson JG. Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. J Clin Psychiatry. 2012 Feb;73(2):216-23. doi: 10.4088/JCP.09m05580. Epub 2011 May 17.
PubMed 21672497
Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.
PubMed 20840778

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Assessment of the Safety, Efficacy, and Practicality of an Algorithm Including Amantadine, Metformin and Zonisamide for the Prevention of Olanzapine-Associated Weight Gain in Outpatients With Schizophrenia
ClinicalTrials.gov ID: NCT00401973
Acronym / sponsor ID: 10768
Conditions: Schizophrenia, Schizoaffective Disorders
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 30 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this study is to answer the following questions:

Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine
Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain
How weight gain associated with olanzapine can affect people
Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Olanzapine	Experimental	Drug: olanzapine, Behavioral: Wellness educationolanzapine plus behavioral information
Olanzapine + Amantadine	Experimental	Drug: olanzapine, Drug: amantadine, Drug: metformin, Drug: zonisamide, Behavioral: Wellness educationOlanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
Olanzapine + Metformin	Experimental	Drug: olanzapine, Drug: amantadine, Drug: metformin, Drug: zonisamide, Behavioral: Wellness educationOlanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

You must have been diagnosed with schizophrenia or schizoaffective disorder
You must be able to visit the doctor's office once every two weeks for three months, then once every four weeks for the next three months with a possible bi-weekly visit during the fifth month
If you are currently taking a medication for schizophrenia or schizoaffective disorder, you have been taking it for at least 30 days without any changes
If you are a female, you must have a negative pregnancy test and be using an effective method of contraception

Key exclusion criteria (5 listed)

You have a diagnosis of bipolar I disorder, diabetes, very high triglyceride level (fasting triglycerides greater than or equal to 500 mg/dL), recent heart attack, stroke, uncontrolled seizures, serious infection, unstable heart disease (such as ischemic heart disease or congestive heart failure), an uncorrected narrow angle glaucoma or human immunodeficiency virus (HIV)
You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood
You have a diagnosis of an eating disorder
You have a history of Parkinson's Disease or any related disorders
You are allergic to sulfa drugs or any of the medications involved in this study

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
olanzapineAlso: LY170053, Zyprexa5-20 milligrams (mg), oral, daily for 22 weeks.	Drug	Olanzapine, Olanzapine + Amantadine, Olanzapine + Metformin
amantadineAmantadine, 100 milligrams (mg), oral, 1 twice a day (BID). Patients who gained greater than 3 kilograms (kg) will switch to metformin. Patients who gained greater than 3 kg after switching to metformin will be switched to zonisamide.	Drug	Olanzapine + Amantadine, Olanzapine + Metformin
metforminMetformin, 500 mg, oral, twice a day (BID) for 2 weeks titrated to 500mg three times a day (TID) thereafter. Patients who gain greater than 3 kilograms (kg) will be switched to amantadine. Patients who gained greater than 3 kg after switching to amantadine will be switched to zonisamide.	Drug	Olanzapine + Amantadine, Olanzapine + Metformin
zonisamideZonisamide, 100-400mg, oral, daily.	Drug	Olanzapine + Amantadine, Olanzapine + Metformin
Wellness educationweight management	Behavioural	Olanzapine, Olanzapine + Amantadine, Olanzapine + Metformin

Primary outcome

Change From Baseline to Endpoint in Weight
Time frame: Baseline to endpoint (22 weeks)

10 secondary outcomes

Mean Change From Baseline to Endpoint in Fasting Triglycerides
Time frame: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Total Cholesterol
Time frame: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol
Time frame: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Glucose
Time frame: Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Hemoglobin A1c
Time frame: Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score
Time frame: Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to endpoint (22 weeks)
Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)
Time frame: Baseline to endpoint (22 weeks)
Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks
Time frame: Baseline to endpoint (22 weeks)

Results and safety

Results posted to the registry on 30 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olanzapine	50	39
Olanzapine + Amantadine	76	50
Olanzapine + Metformin	73	50

Primary outcome: Change From Baseline to Endpoint in Weight

Time frame: Baseline to endpoint (22 weeks). Least squares mean (Standard Error). Unit: kilograms

Measure	Olanzapine n = 40	Olanzapine + Amantadine n = 50	Olanzapine + Metformin n = 51
Value	2.76 (0.75)	2.40 (0.65)	0.65 (0.63)

Olanzapine vs Olanzapine + Amantadine vs Olanzapine + Metformin: p = 0.065, Mixed Models Analysis
Olanzapine vs Olanzapine + Amantadine: p = 0.113, Mixed Models Analysis
Olanzapine vs Olanzapine + Metformin: p = 0.036, Mixed Models Analysis

Population analysed: All randomized participants with baseline and at least one postbaseline measurement.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olanzapine	5 of ?	26 of ?	Not reported
Olanzapine + Amantadine	4 of ?	38 of ?	Not reported
Olanzapine + Metformin	4 of ?	46 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21672497Hoffmann VP, Case M, Jacobson JG. Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. J Clin Psychiatry. 2012 Feb;73(2):216-23. doi: 10.4088/JCP.09m05580. Epub 2011 May 17.
Derived from this study: PubMed 20840778Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

15 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olanzapine, amantadine and metformin in people with Schizophrenia and Schizoaffective Disorders, run by Eli Lilly and Company at 15 sites in 7 countries.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 6 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Puerto Rico, Brazil, Israel, Mexico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline to Endpoint in Weight (time frame: Baseline to endpoint (22 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401973, which also lists 2 linked publications.

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 6 Oct 2009; AzTrials last refreshed its copy on 8 Nov 2026.