Status:
COMPLETED
Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Overweight
Obesity
Eligibility:
All Genders
25-60 years
Phase:
PHASE2
Brief 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 hormo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00444561
Start Date
August 1 2004
End Date
May 1 2005
Last Update
June 11 2015
Active Locations (10)
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1
Research Site
Chula Vista, California, United States
2
Research Site
Long Beach, California, United States
3
Research Site
San Diego, California, United States
4
Research Site
DeLand, Florida, United States