A Study to Examine the Long Term 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; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189514

137OB-201E

Details and patient eligibility

About

This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Enrollment: 210 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subject has completed Protocol 137OB-201.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: pramlintide acetate

2

Experimental group

Treatment:

Drug: pramlintide acetate

3

Experimental group

Treatment:

Drug: pramlintide acetate

4

Placebo Comparator group

Treatment:

Drug: placebo