- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444561
Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
June 10, 2015 updated by: AstraZeneca
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
184
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Chula Vista, California, United States
- Research Site
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Long Beach, California, United States
- Research Site
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San Diego, California, United States
- Research Site
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Florida
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DeLand, Florida, United States
- Research Site
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Fort Lauderdale, Florida, United States
- Research Site
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Kentucky
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Lexington, Kentucky, United States
- Research Site
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Louisiana
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Baton Rouge, Louisiana, United States
- Research Site
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New Orleans, Louisiana, United States
- Research Site
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Montana
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Butte, Montana, United States
- Research Site
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Texas
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San Antonio, Texas, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Pramlintide acetate (AC137)
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.
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Clear, colorless, sterile solution for SC administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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73 Days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects.
Time Frame: 73 Days
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73 Days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
May 1, 2005
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
March 6, 2007
First Submitted That Met QC Criteria
March 6, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Estimate)
June 11, 2015
Last Update Submitted That Met QC Criteria
June 10, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 137-160
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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