NCT01571297

Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Motus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of RM-131 on gastric emptying, gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 and placebo) will be administered subcutaneously in a blinded fashion.

Conditions

• Diabetes Mellitus
• Diabetes Mellitus Complications
• Gastroparesis

Interventions

Type	Name	Description
DRUG	RM-131	Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.
DRUG	Placebo	Placebo given subcutaneously for 35 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-04-05
• Last updated: 2016-09-23

Locations

30 sites across 1 country: United States