OverweightPhase 2NCT00402077
A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects
A Phase 2 study testing pramlintide acetate, sibutramine and phentermine in people with Overweight and Obesity, run by AstraZeneca at 16 sites in United States.
Trial summary
This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- pramlintide acetate, sibutramine and phentermine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 16 sitesUnited States
- Study dates
- Nov 2006to Aug 2007
- 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
- Is obese with a Body Mass Index (BMI) >=30 kg/m^2 to <=50 kg/m^2 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
- Has been obese or overweight for at least one year prior to study start
- Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin
Who cannot join
- Is currently enrolled in or is planning to enroll in a formal weight-loss program
- Is unwilling or unable to participate in a lifestyle intervention program as part of the study
- Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications
- Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
- Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
- Has previously used pramlintide either by prescription or as part of a clinical study
- Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start
- Has donated blood within 2 months before study start, or is planning to donate blood during the study
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Research Site
Austin, Texas
Research Site
Birmingham, Alabama
Research Site
Chula Vista, California
Research Site
Eugene, Oregon
Research Site
La Jolla, California
Research Site
Los Angeles, California
Research Site
Louisville, Kentucky
Research Site
Miami, Florida
Research Site
New York, New York
Research Site
Pembroke Pines, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Raleigh, North Carolina
Research Site
San Antonio, Texas
Research Site
Statesville, North Carolina
Research Site
Walnut Creek, California
About this study
Official title: A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects
This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.
- Conditions
- Overweight, Obesity
- Being tested
- pramlintide acetate, sibutramine, phentermine, placebo
- Keywords
- overweight, obesity, pramlintide, Symlin, sibutramine, Meridia, phentermine, Amylin
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pramlintide acetateDrug
Also called Symlin
subcutaneous injection, three times a day, 120mcg
sibutramineDrug
Also called Meridia
oral tablet, once a day, 10mg
phentermineDrug
Also called Adipex-P, Fastin, Obenix, Oby-Trim
oral tablet, once a day, 37.5mg
placeboDrug
subcutaneous injection, three times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: pramlintide acetate |
| 2 | Experimental | Not described Receives: Drug: pramlintide acetate; Drug: sibutramine |
| 3 | Experimental | Not described Receives: Drug: pramlintide acetate; Drug: phentermine |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All treatment-emergent adverse events occurring during the 24-week treatment period
Measured: 24 weeks
Absolute change in body weight from baseline to Week 12
Measured: 12 weeks
Secondary outcomes (7)
Percent change in body weight from baseline to Week 12
Measured: 12 weeks
Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
Measured: 24 weeks
Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
Measured: 24 weeks
Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
Measured: 24 weeks
Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
Measured: 24 weeks
Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Measured: 24 weeks
Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Porter, MD, Study director, Amylin Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402077
- Sponsor's protocol ID
- AFA203
- Status last verified
- Feb 2015
- First submitted
- 17 Nov 2006
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT00402077
- Acronym / sponsor ID
- AFA203
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, pramlintide, Symlin, sibutramine, Meridia, phentermine, Amylin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Nov 2006 (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 study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pramlintide acetate |
| 2 | Experimental | Drug: pramlintide acetate, Drug: sibutramine |
| 3 | Experimental | Drug: pramlintide acetate, Drug: phentermine |
| 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is obese with a Body Mass Index (BMI) >=30 kg/m^2 to <=50 kg/m^2 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
- Has been obese or overweight for at least one year prior to study start
- Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin
Key exclusion criteria (8 listed)
- Is currently enrolled in or is planning to enroll in a formal weight-loss program
- Is unwilling or unable to participate in a lifestyle intervention program as part of the study
- Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications
- Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
- Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
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 |
|---|---|---|
| pramlintide acetateAlso: Symlinsubcutaneous injection, three times a day, 120mcg | Drug | 1, 2, 3 |
| sibutramineAlso: Meridiaoral tablet, once a day, 10mg | Drug | 2 |
| phentermineAlso: Adipex-P, Fastin, Obenix, Oby-Trimoral tablet, once a day, 37.5mg | Drug | 3 |
| placebosubcutaneous injection, three times a day | Drug | 4 |
Primary outcome
All treatment-emergent adverse events occurring during the 24-week treatment period
Time frame: 24 weeks
Absolute change in body weight from baseline to Week 12
Time frame: 12 weeks
7 secondary outcomes
Percent change in body weight from baseline to Week 12
Time frame: 12 weeks
Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
Time frame: 24 weeks
Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
Time frame: 24 weeks
Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
Time frame: 24 weeks
Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
Time frame: 24 weeks
Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Time frame: 24 weeks
Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Time frame: 24 weeks
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 6 Mar 2015.
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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.
Lisa Porter, MD study director
Amylin Pharmaceuticals, LLC.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pramlintide acetate, sibutramine and phentermine in people with Overweight and Obesity, run by AstraZeneca at 16 sites 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?
The sponsor lists 3 inclusion and 8 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 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. 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 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?
All treatment-emergent adverse events occurring during the 24-week treatment period (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 6 Mar 2015.