OverweightPhase 2NCT00444561
Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
A Phase 2 study testing pramlintide acetate in people with Overweight and Obesity, run by AstraZeneca at 10 sites in United States.
Trial summary
This exploratory study is designed to evaluate various pharmacodynamic effects of subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and postmenopausal female (not on hormone replacement therapy) subjects. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- pramlintide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is <6'3" (190.5 cm) tall and weighs <300 lb (~136.3 kg)
- Is obese with a body mass index (BMI) >=30 kg/m^2 to <=45 kg/m^2 and with a history consistent with progressive weight gain and development of obesity not secondary to drastic or traumatic initiating events (e.g., excessive weight gain due to cessation of smoking)
- Is a nonsmoker (never smoked or has not smoked for at least 2 years)
- Does not have a clinical diagnosis of diabetes
- Has not had a major change in daily physical activity within 2 months prior to study start (e.g., initiation of an exercise program)
- Usually consumes three major meals (morning, midday, and evening) each day and rarely (less than once a week) wakes up to eat during the night
Who cannot join
- Is currently enrolled in a weight loss program or plans to enroll in a weight loss or exercise program within the next 3 months
- Is currently treated or expected to require or undergo treatment or has been treated within 2 months before screening with medications that are excluded:
- Over the counter antiobesity agents including herbal supplements or prescription antiobesity agents approved for the long-term (including orlistat [Xenical] and sibutramine [Meridia]) and the short-term (including phentermine [Adipex-P, Celltech, Pro-Fast SA, Pro-Fast SR, Fastin, Oby trim, Zantryl, Teramine, Phentride, Phentercot, Obephen, Oby-cap], mazindol [Sanorex and Mazanor], methamphetamine [Desoxyn], diethylpropion [Tenuate and Tenuate Dospan], phendimetrazine [Bontril, Prelu-2, Melfiat 105, Unicelles, X-Trozine, Plegine, Adipost, Obezine, Phendiet-105, PT 105] and benzphetamine [Didrex]) treatment of obesity
- Systemic steroids by oral, intravenous, or intramuscular route or potent topical steroids that are known to result in high systemic absorption
- Alpha- or Beta-Blockers, centrally acting sympathicolytic or sympathicomimetic agents, reserpin, guanethidine, etc.
- Psychotropic medications (e.g., tricyclic antidepressants, monoamine oxidase [MAO] inhibitors, selective serotonin reuptake inhibitors [SSRIs], neuroleptics, lithium, and benzodiazepines)
Show all 10Show fewer
- Hypnotic-sedative medications or medications that may affect sleeping behavior including medications containing caffeine
- Drugs that directly affect gastrointestinal motility, including but not limited to: metoclopramide (Reglan®) and cisapride (Propulsid®); and macrolide antibiotics such as erythromycin and newer derivatives
- Has received any investigational drug within 3 months before study start
- Has participated previously in a study using pramlintide
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Baton Rouge, Louisiana
Research Site
Butte, Montana
Research Site
Chula Vista, California
Research Site
DeLand, Florida
Research Site
Fort Lauderdale, Florida
Research Site
Lexington, Kentucky
Research Site
Long Beach, California
Research Site
New Orleans, Louisiana
Research Site
San Antonio, Texas
Research Site
San Diego, California
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
This exploratory study is designed to evaluate various pharmacodynamic effects of subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and postmenopausal female (not on hormone replacement therapy) subjects. The study will also assess the safety and tolerability of pramlintide administered by SC infusion or injection.
- Conditions
- Overweight, Obesity
- Being tested
- pramlintide acetate
- Keywords
- pramlintide, Symlin, 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
Clear, colorless, sterile solution for SC administration
| Study group | Role | What they receive |
|---|---|---|
| Pramlintide acetate (AC137) | Active comparator | Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC administration. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL. Receives: Drug: pramlintide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate various pharmacodynamic effects (including effects on body weight, food intake, and other parameters) of subcutaneously (SC) infused or injected pramlintide in obese subjects.
Measured: 73 Days
Secondary outcomes (1)
To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects.
Measured: 73 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startAug 2004
- Primary completionMay 2005
- Study completionMay 2005
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 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
- NCT00444561
- Sponsor's protocol ID
- 137-160
- Status last verified
- May 2015
- First submitted
- 6 Mar 2007
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
- ClinicalTrials.gov ID
- NCT00444561
- Acronym / sponsor ID
- 137-160
- Conditions
- Overweight, Obesity
- Keywords
- pramlintide, Symlin, Amylin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 8 Mar 2007 (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 exploratory study is designed to evaluate various pharmacodynamic effects of subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and postmenopausal female (not on hormone replacement therapy) subjects. The study will also assess the safety and tolerability of pramlintide administered by SC infusion or injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pramlintide acetate (AC137) | Active comparator | Drug: pramlintide acetatePramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC administration. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is <6'3" (190.5 cm) tall and weighs <300 lb (~136.3 kg)
- Is obese with a body mass index (BMI) >=30 kg/m^2 to <=45 kg/m^2 and with a history consistent with progressive weight gain and development of obesity not secondary to drastic or traumatic initiating events (e.g., excessive weight gain due to cessation of smoking)
- Is a nonsmoker (never smoked or has not smoked for at least 2 years)
- Does not have a clinical diagnosis of diabetes
- Has not had a major change in daily physical activity within 2 months prior to study start (e.g., initiation of an exercise program)
Key exclusion criteria (10 listed)
- Is currently enrolled in a weight loss program or plans to enroll in a weight loss or exercise program within the next 3 months
- Is currently treated or expected to require or undergo treatment or has been treated within 2 months before screening with medications that are excluded:
- Has received any investigational drug within 3 months before study start
- Has participated previously in a study using pramlintide
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 acetateClear, colorless, sterile solution for SC administration | Drug | Pramlintide acetate (AC137) |
Primary outcome
To evaluate various pharmacodynamic effects (including effects on body weight, food intake, and other parameters) of subcutaneously (SC) infused or injected pramlintide in obese subjects.
Time frame: 73 Days
1 secondary outcome
To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects.
Time frame: 73 Days
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.
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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.
10 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 Overweight and Obesity, run by AstraZeneca at 10 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 6 inclusion and 10 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 10 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. 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?
To evaluate various pharmacodynamic effects (including effects on body weight, food intake, and other parameters) of subcutaneously (SC) infused or injected pramlintide in obese subjects. (time frame: 73 Days). 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 11 Jun 2015.