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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00444561

Collaborator

(none)

184

Enrollment

Locations

Arm

Duration (Months)

18.4

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Aug 1, 2004

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Arms and Interventions

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

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

Outcome Measures

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. [73 Days]

Secondary Outcome Measures

To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects. [73 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
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
5	Research Site	Fort Lauderdale	Florida	United States
6	Research Site	Lexington	Kentucky	United States
7	Research Site	Baton Rouge	Louisiana	United States
8	Research Site	New Orleans	Louisiana	United States
9	Research Site	Butte	Montana	United States
10	Research Site	San Antonio	Texas	United States