MedTrace Logo

Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

NCT00819234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2015-04-15

Study results available
· View outcomes & findings →

Summary

Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.

Conditions

Interventions

DRUG

Placebo

placebo pramlintide and placebo metreleptin twice daily

DRUG

Pramlintide and Metreleptin

Subcutaneous injection, twice daily

Sponsors & Collaborators

Principal Investigators

  • Jean Chan, MD · Amylin Pharmaceuticals, LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-10-31
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00819234 on ClinicalTrials.gov