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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.
Placebo given subcutaneously for 35 days
Unnamed facility
Dothan, Alabama, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
North Little Rock, Arkansas, United States
Unnamed facility
Concord, California, United States
Unnamed facility
Lomita, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
Inverness, Florida, United States
Unnamed facility
Miami, Florida, United States
...and 20 more locations
Effect of RM-131 on gastric emptying time
Change from baseline in gastric half-emptying time (t½)
Time frame: Screening and Day 28
Effect of RM-131 on symptoms of gastroparesis
Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary
Time frame: Baseline, daily for 28 days, and Day 35
Safety and tolerability of RM-131
Assessment of adverse events and clinical laboratory evaluations
Time frame: From Screening through Day 35
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.