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Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

NCT00673387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2015-04-15

Study results available
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Summary

A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.

Conditions

Interventions

DRUG

pramlintide acetate

subcutaneous injection, twice a day

DRUG

metreleptin

subcutaneous injection, twice a day

DRUG

placebo-P

subcutaneous injection, twice a day

DRUG

placebo-M

subcutaneous injection, twice a day

Sponsors & Collaborators

Principal Investigators

  • Vice President Research and Development, MD · Amylin Pharmaceuticals, LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-04-30
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

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 NCT00673387 on ClinicalTrials.gov