Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

NCT00819234 ↗

Phase 2 Completed 274 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.

Timeline

Start: 2008-11
Primary completion: 2009-10
Completion: 2009-11

Outcome

Met primary endpoint

registry p = 0.0135; LS Mean Difference -7.23 (95% CI -12.93 to -1.54) NCT00819234 ↗

registry p = 0.0168; LS Mean -6.55 (95% CI -11.89 to -1.21) NCT00819234 ↗

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	—	Subcutaneous