A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: pramlintide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00112021

137OB-201

Details and patient eligibility

About

This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Enrollment: 400 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening.
• Usually consumes at least three major meals (morning, midday, and evening) each day.

Exclusion criteria

• Is currently enrolled in a formal weight-loss program.
• Has had liposuction within 1 year before screening or is planning to have liposuction during the study.
• Has received any investigational drug within 3 months before screening.
• Has previously participated in a study using pramlintide.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Pramlintide Acetate

Experimental group

Treatment:

Drug: pramlintide acetate

Placebo

Placebo Comparator group