RM-131 in patients with vomiting symptoms and diabetic gastroparesis
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
IRAS ID
170871
Contact name
Yan Yiannakou
Contact email
Sponsor organisation
Motus Therapeutics, Inc.
Eudract number
2014-005623-27
Duration of Study in the UK
0 years, 10 months, 13 days
Research summary
Gastroparesis is a chronic (long-lasting) condition in which the stomach cannot empty itself in the normal way. This causes food to pass through the stomach slower than usual, leading to symptoms such as nausea, bloating, stomach pain and vomiting, which can lead to dehydration and malnutrition. Gastroparesis is commonly found in people with diabetes as high levels of sugar in the blood can damage nerves in the stomach.
There is no known cure for gastroparesis. Current therapies include dietary modifications such as replacing big meals with small frequent meals and avoiding fatty foods, and medications which can help improve symptoms of the condition. In more severe cases, treatments include Botox injections into the opening of the stomach, or surgery to insert a device which sends electrical pulses to the stomach muscles to help control vomiting. There is an unmet need for the use of a treatment with lesser risks and side effects.
Rhythm Pharmaceuticals, Inc. have developed a new drug, RM-131, that has been designed to activate an enzyme associated with increasing the rate at which the stomach is emptied.
This study is being done to see if RM-131 can help reduce vomiting and associated symptoms in people with diabetic gastroparesis.
This is a multicentre study which will take place across Europe, United States and Israel. It is anticipated that approximately 395 patients will be enrolled worldwide, 9 of those in the UK.
This is a double-blind, randomised, placebo-controlled, multiple-dose study meaning that patients will be randomly assigned to receive RM-131 study drug (10 µg, 30 µg, or 100 µg) or placebo (looks like the study drug but with no active ingredient) via injection twice daily for 12 weeks. Neither the patient nor the study doctor will know which medication is being given.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0125
Date of REC Opinion
28 May 2015
REC opinion
Further Information Favourable Opinion