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

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ClinicalTrials.gov Identifier: NCT00444561
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : June 11, 2015
Information provided by (Responsible Party):

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 hormone replacement therapy) subjects. The study will also assess the safety and tolerability of pramlintide administered by SC infusion or injection.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: pramlintide acetate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2004
Primary Completion Date : May 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: pramlintide acetate
Clear, colorless, sterile solution for SC administration

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects. [ Time Frame: 73 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444561

United States, California
Research Site
Chula Vista, California, United States
Research Site
Long Beach, California, United States
Research Site
San Diego, California, United States
United States, Florida
Research Site
DeLand, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
United States, Kentucky
Research Site
Lexington, Kentucky, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
Research Site
New Orleans, 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
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00444561     History of Changes
Other Study ID Numbers: 137-160
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: May 2015

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action