ObesityPhase 2NCT00104507
Safety and Efficacy of APD356 in the Treatment of Obesity
A Phase 2 study testing APD356 in people with Obesity, run by Eisai Inc. at 1 site in United States.
Trial summary
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity. The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- APD356
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to May 2005
- 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
- Healthy volunteers accepted
- Adult, Older adult
- Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive)
- Body Mass Index (BMI) of 30-45 Kg/m^2.
- Non-smoker
- No concomitant medications
- No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.
The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.
Read the detailed description
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.
- Conditions
- Obesity
- Being tested
- APD356
- Keywords
- Serotonin, 5-HT2c, Satiety, Obesity, Appetite suppressant, Weight Loss, Overweight
- Medical subject headings
- Obesity, Anorexia, Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD356Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Secondary outcomes (2)
Safety
Changes in waist circumference, hip circumference and waist/hip ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2005 (estimated)
- Study startDec 2004
- Study completionMay 2005
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.
- More trials run by Eisai Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104507
- Sponsor's protocol ID
- APD356-003
- Status last verified
- Dec 2006
- First submitted
- 1 Mar 2005
- Last updated
- 12 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
- ClinicalTrials.gov ID
- NCT00104507
- Acronym / sponsor ID
- APD356-003
- Conditions
- Obesity
- Keywords
- Serotonin, 5-HT2c, Satiety, Obesity, Appetite suppressant, Weight Loss, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 2 Mar 2005 (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 is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.
The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.
Detailed description
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| APD356 | Drug | – |
Primary outcome
Change in body weight
2 secondary outcomes
Safety
Changes in waist circumference, hip circumference and waist/hip ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- obesity informationLink provided by the sponsor.
- N. American Association for the Study of Obesity web pageLink provided by the sponsor.
- sponsor company web pageLink provided by the sponsor.
- Pennington Biomedical Research Center home web pageLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APD356 in people with Obesity, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. 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 12 Sep 2019.