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A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

NCT00392925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2015-04-14

Study results available
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Summary

This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.

Conditions

Interventions

DRUG

pramlintide acetate 360 mcg

subcutaneous injection, twice a day, 360mcg

DRUG

metreleptin

subcutaneous injection, twice a day, 5mg

DRUG

placebo-pramlintide 600 uL

twice a day

DRUG

placebo-metreleptin 1 mL

twice a day

DRUG

Pramlintide acetate 180 mcg

subcutaneous injection twice a day, 180 mcg

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
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-09-30
Completion
2007-09-30

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 NCT00392925 on ClinicalTrials.gov