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

Study identifier:137-160

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

overweight

Phase

Phase 2

Healthy volunteers

Study drug

pramlintide acetate

Sex

All

Actual Enrollment

184

Study type

Interventional

Age

25 Years - 60 Years

Date

Study Start Date: 01 Aug 2004

Primary Completion Date: 01 May 2005

Study Completion Date: -

Study design

Allocation: Randomized
Endpoint Classification: Pharmacodynamics
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals

Collaborators

N/A

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Lisa Porter

Amylin Pharmaceuticals