Study identifier:DFA102
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction with Pramlintide in Obese and Overweight Subjects.
overweight
Phase 2
No
pramlintide acetate, metreleptin, placebo-P, placebo-M
All
636
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
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.
Location
Location
Boston, MA, United States
Location
Salt Lake City, UT, United States
Location
New York City, NY, United States
Location
St. Louis, MO, United States
Location
Baton Rouge, LA, United States
Location
Austin, TX, United States
Location
Eugene, OR, United States
Location
Jacksonville, FL, United States
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo-P + Placebo-M Placebo matched to pramlintide BID plus placebo matched to metreleptin BID | Drug: placebo-P subcutaneous injection, twice a day Other Name: Placebo matched to pramlintide Drug: placebo-M subcutaneous injection, twice a day Other Name: Placebo matched to Metreleptin |
Experimental: Pramlintide 360 mcg + Placebo-M 360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID | Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: placebo-M subcutaneous injection, twice a day Other Name: Placebo matched to Metreleptin |
Experimental: Placebo-P + Metreleptin 5.0 mg Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID | Drug: metreleptin subcutaneous injection, twice a day Drug: placebo-P subcutaneous injection, twice a day Other Name: Placebo matched to pramlintide |
Experimental: Pramlintide 180 mcg + Metreleptin 2.5 mg Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID | Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day |
Experimental: Pramlintide 180 mcg + Metreleptin 5.0 mg Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID | Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day |
Experimental: Pramlintide 360 mcg + Metreleptin 1.25 mg Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID | Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day |
Experimental: Pramlintide 360 mcg + Metreleptin 2.5 mg Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID | Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day |
Experimental: Pramlintide 360 mcg + Metreleptin 5.0 mg Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID | Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day |
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