Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

Summary

The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.

Timeline

Start

2015-01-29

Primary completion

2016-06-09

Completion

2016-06-09

Outcome

Missed primary endpoint

paper Patients given relamorelin had a 75% reduction in vomiting frequency compared with baseline, but this difference was not significant compared with the placebo group. PMID 28760384 ↗

Publications

• Camilleri M, Lembo A, McCallum R, Tourkodimitris S, Kemps L, Miller MB, Bertelsen K, Iacob A. Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Aliment Pharmacol Ther. 2020 Jun;51(11):1139-1148. doi: 10.1111/apt.15711. Epub 2020 Apr 17.
• Camilleri M, McCallum RW, Tack J, Spence SC, Gottesdiener K, Fiedorek FT. Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study. Gastroenterology. 2017 Nov;153(5):1240-1250.e2. doi: 10.1053/j.gastro.2017.07.035. Epub 2017 Jul 29.

Drugs

Indications