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An Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
This study has been completed.
First Received: March 6, 2007   No Changes Posted
Sponsored by: Amylin Pharmaceuticals, Inc.
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00444561
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Drug: pramlintide acetate
Phase II

MedlinePlus related topics: Obesity
Drug Information available for: Pramlintide Pramlintide acetate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics 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

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects.

Estimated Enrollment: 184
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444561

Locations
United States, California
Research Site
Long Beach, California, United States
Research Site
Chula Vista, California, United States
Research Site
San Diego, California, United States
United States, Florida
Research Site
Fort Lauderdale, Florida, United States
Research Site
DeLand, Florida, United States
United States, Kentucky
Research Site
Lexington, Kentucky, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
Research Site
Baton Rouge, Louisiana, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, Inc.
  More Information

No publications provided

Study ID Numbers: 137-160
Study First Received: March 6, 2007
Last Updated: March 6, 2007
ClinicalTrials.gov Identifier: NCT00444561     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
pramlintide
Symlin
Amylin

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Hypoglycemic Agents
Amylin
Nutrition Disorders
Pramlintide
Overnutrition
Overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Hypoglycemic Agents
Physiological Effects of Drugs
Nutrition Disorders
Pramlintide
Overnutrition
Overweight
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009