ObesityPhase 2NCT00189514
A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
A Phase 2 study testing pramlintide acetate in people with Obesity, run by AstraZeneca at 21 sites in United States.
Trial summary
This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- pramlintide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 21 sitesUnited States
- Study dates
- Sep 2005to Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has completed Protocol 137OB-201.
Who cannot join
None listed.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Research Site
Augusta, Georgia
Research Site
Austin, Texas
Research Site
Baton Rouge, Louisiana
Research Site
Butte, Montana
Research Site
Chicago, Illinois
Research Site
Chula Vista, California
Research Site
Cincinnati, Ohio
Research Site
Detroit, Michigan
Research Site
Edina, Minnesota
Research Site
Indianapolis, Indiana
Research Site
Miami, Florida
Research Site
New York, New York
Research Site
Olympia, Washington
Research Site
Overland Park, Kansas
Research Site
Philadelphia, Pennsylvania
Research Site
Portland, Oregon
Research Site
Salt Lake City, Utah
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
St Louis, Missouri
Research Site
Walnut Creek, California
About this study
Official title: Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
- Conditions
- Obesity
- Being tested
- pramlintide acetate, placebo
- Keywords
- obesity, weight loss, Amylin, pramlintide
- Medical subject headings
- Obesity, Weight Loss
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, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
placeboDrug
subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: pramlintide acetate |
| 2 | Experimental | Not described Receives: Drug: pramlintide acetate |
| 3 | Experimental | Not described Receives: Drug: pramlintide acetate |
| 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.
Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.
Measured: open ended
Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.
Measured: open ended
Secondary outcomes (1)
Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.
Measured: open ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 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
- NCT00189514
- Sponsor's protocol ID
- 137OB-201E
- Status last verified
- May 2015
- First submitted
- 12 Sep 2005
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep;31(9):1816-23. doi: 10.2337/dc08-0029. Epub 2008 Jun 20.
PubMed 18753666
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
- ClinicalTrials.gov ID
- NCT00189514
- Acronym / sponsor ID
- 137OB-201E
- Conditions
- Obesity
- Keywords
- obesity, weight loss, Amylin, pramlintide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Sep 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 long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pramlintide acetate |
| 2 | Experimental | Drug: pramlintide acetate |
| 3 | Experimental | Drug: pramlintide acetate |
| 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has completed Protocol 137OB-201.
Key exclusion criteria (0 listed)
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, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg | Drug | 1, 2, 3 |
| placebosubcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate | Drug | 4 |
Primary outcome
Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.
Time frame: open ended
Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.
Time frame: open ended
1 secondary outcome
Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.
Time frame: open ended
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 11 Jun 2015.
- Derived from this study: PubMed 18753666Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep;31(9):1816-23. doi: 10.2337/dc08-0029. Epub 2008 Jun 20.
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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.
21 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 in people with Obesity, run by AstraZeneca at 21 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 1 inclusion and 0 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 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. (time frame: open ended). 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?
On the ClinicalTrials.gov record for NCT00189514, which also lists 1 linked publication.
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 11 Jun 2015.