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

NCT00189514 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2015-06-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

pramlintide acetate

Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg

DRUG

placebo

subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate

Sponsors & Collaborators

Principal Investigators

  • Lisa Porter, MD · Amylin Pharmaceuticals, LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00189514 on ClinicalTrials.gov