Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

Phase 2 Completed 636 enrolled AstraZeneca

RandomizedFactorialDouble-blindTreatment

Summary

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.

Timeline

Start: 2008-04
Primary completion: 2009-04
Completion: 2009-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Pramlintide 180 mcg + Metreleptin 2.5 mg; p <0.0001; t-test, 2 sided NCT00673387 ↗

Publications

Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metreleptin	Protein / enzyme biologic	1.25 mg	Subcutaneous
Subject	Metreleptin	Protein / enzyme biologic	2.5 mg	Subcutaneous
Subject	Metreleptin	Protein / enzyme biologic	5 mg	Subcutaneous
Subject	Pramlintide	Peptide	180 ug	Subcutaneous
Subject	Pramlintide	Peptide	360 ug	Subcutaneous