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Relamorelin trial in diabetic gastroparesis completes enrollment
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Enrollment concluded in a phase 2b clinical trial of relamorelin for the treatment of gastroparesis in patients with type 1 and type 2 diabetes, the manufacturer announced.
Relamorelin (RM-131, Motus) is a ghrelin agonist being developed for treating patients with diabetic gastroparesis or GI functional disorders, which works by stimulating GI motility in these patients, according to a press release. The FDA has granted fast track review status to relamorelin for the indication of diabetic gastroparesis, and phase 2a clinical trials in diabetic gastroparesis and chronic constipation have already been completed.
The current phase 2b randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of relamorelin in 396 patients with diabetic gastroparesis receiving dosing regimens ranging from 10 mcg to 100 mcg given twice per day for 3 months. Patients were recruited at clinical centers in the U.S. and Europe. Researchers will evaluate the effect of relamorelin on gastroparesis signs and symptoms and GI motility.
The previous phase 2a trial in diabetic gastroparesis evaluated the effects of relamorelin in 204 patients, who experienced significant improvements in gastric emptying and vomiting symptoms, as well as other symptoms in certain patient subgroups, according to the press release.