A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction with Pramlintide in Overweight and Obese Subjects
Study identifier:DFA101
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2A, Randomized, Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Effect on Body Weight of Recombinant-Methionyl Human Leptin Administered in Conjunction with Pramlintide in Overweight and Obese Subjects
Medical condition
overweight
Phase
Phase 2
Healthy volunteers
No
Study drug
pramlintide acetate 360 mcg, metreleptin, placebo-pramlintide 600 uL, placebo-metreleptin 1 mL, Pramlintide acetate 180 mcg
Sex
All
Actual Enrollment
177
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Oct 2006
Primary Completion Date: 01 Sept 2007
Study Completion Date: 01 Sept 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
N/A
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Placebo and Metreleptin Placebo-pramlintide 600 microliters (µL) twice a day (BID) and metreleptin (recombinant-methionyl human leptin) 5 milligram (mg) BID, 20 weeks | Drug: metreleptin subcutaneous injection, twice a day, 5mg Other Name: recombinant-methionyl human leptin Drug: placebo-pramlintide 600 uL twice a day |
| Experimental: Pramlintide Acetate and Placebo Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and placebo-metreleptin 1 mL BID, 20 weeks | Drug: pramlintide acetate 360 mcg subcutaneous injection, twice a day, 360mcg Other Name: SYMLIN® Drug: placebo-metreleptin 1 mL twice a day |
| Experimental: Pramlintide Acetate and Metreleptin Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and metreleptin (recombinant-methionyl human leptin) 5 mg BID, 20 weeks | Drug: pramlintide acetate 360 mcg subcutaneous injection, twice a day, 360mcg Other Name: SYMLIN® Drug: metreleptin subcutaneous injection, twice a day, 5mg Other Name: recombinant-methionyl human leptin |
| Other: Lead-In Period During the Lead-In Period before a participant was randomized to a study arm, the participant received 180 mcg pramlintide acetate twice a day (BID) for 2 weeks, followed by 360 mcg pramlintide acetate BID for 2 weeks (total of 4 weeks in the Lead-In Period). | Drug: pramlintide acetate 360 mcg subcutaneous injection, twice a day, 360mcg Other Name: SYMLIN® Drug: Pramlintide acetate 180 mcg subcutaneous injection twice a day, 180 mcg Other Name: SYMLIN® |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
