Study identifier:DFA104
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-Blind, Placebo-Controled, Multicenter Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects Following A Low‑Calorie Diet Lead-In
obesity
Phase 2
No
Pramlintide+Metreleptin, Placebo
All
213
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Takeda Pharmaceuticals North America, Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group A Pramlintide+Metreleptin | Drug: Pramlintide+Metreleptin Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks. |
Placebo Comparator: Group B Placebo | Drug: Placebo Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses. |