ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder

Summary

The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33) compared with placebo in adults with binge-eating disorder (BED). An additional objective is to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with binge-eating disorder.

Timeline

Start

2010-05

Primary completion

2011-05

Completion

2011-06

Outcome

Missed primary endpoint

paper There was no significant difference between treatment groups in binge eating episode frequency or any other measure of binge eating, body weight, or eating pathology. PMID 23381803 ↗

paper In this preliminary proof-of-concept study in BED, ALKS-33 did not separate from placebo. PMID 23381803 ↗

Publications

• McElroy SL, Guerdjikova AI, Blom TJ, Crow SJ, Memisoglu A, Silverman BL, Ehrich EW. A placebo-controlled pilot study of the novel opioid receptor antagonist ALKS-33 in binge eating disorder. Int J Eat Disord. 2013 Apr;46(3):239-45. doi: 10.1002/eat.22114. Epub 2013 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Samidorphan	Small molecule	—	Oral

Indications