Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
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.
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