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news.Rhythm has initiated a Phase IIb clinical trial of relamorelin (RM-131) to treat gastroparesis in patients with type 1 and type 2 diabetes.
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Relamorelin is Rhythm’s Phase II ghrelin agonist being developed for the treatment of diabetic gastroparesis and gastrointestinal (GI) functional disorders.
Ghrelin is a peptide hormone produced in the stomach that stimulates GI motility.
Actavis has an exclusive option to acquire Rhythm’s wholly owned subsidiary, Rhythm Pharmaceuticals, upon the completion of the Phase IIb trial.
The randomized, double-blind, placebo-controlled trial is designed to evaluate the effect of relamorelin on signs and symptoms of gastroparesis, GI motility and safety in patients with diabetic gastroparesis.
The trial will evaluate the safety and efficacy of dosing regimens ranging from 10 to 100mcg administered twice daily over three months.
A total of 400 patients with diabetic gastroparesis will be enrolled in the trial at clinical sites in the US and Europe.
Rhythm chief medical officer Dr Fred Fiedorek said: "This is the second of two studies assessing the efficacy and safety of relamorelin for the treatment of diabetic gastroparesis.
"This Phase IIb study is designed to expand our understanding of RM-131’s profile for treating diabetic patients with both moderate and severe gastroparesis, prior to the initiation of Phase III registration studies."
The company has already completed two successful Phase II clinical trials with relamorelin.