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

Inclusion Criteria:

- Able to provide written informed consent prior to any study procedures and be willing
and able to comply with study procedures.

- Type 1 or Type 2 diabetes mellitus with HbA1c ≤11% at screening.

- Diabetic gastroparesis defined as at least 3 months history of symptoms suggestive of
gastroparesis on an ongoing basis.

- Average Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) > 2.6 during Visit
2.

- History of nausea and/or vomiting/emesis at least once a week during the 2 weeks
prior to Visit 1.

- Delayed gastric emptying confirmed at screening by abnormal gastric emptying breath
test (GEBT), defined as half-emptying time (t½) > 79 minutes.

- Stable concomitant medications defined as no changes in regimen for at least 2 weeks
prior to Visit 2.

- No use of metoclopramide, erythromycin or anti-emetics for at least 2 weeks prior to
Visit 2.

- Body mass index > 18 kg/m2.

- Female patients must have negative serum or urine pregnancy tests and must not be
lactating. For females able to bear children, a hormonal (i.e., oral, implantable,
or injectable) and single-barrier method, or a double-barrier method of birth control
must be used throughout the study. Female patients unable to bear children must have
this documented in the electronic case report form (eCRF) (i.e., tubal ligation,
hysterectomy, or post-menopausal [defined as a minimum of one year since the last
menstrual period]). Post-menopausal status will be confirmed by FSH.

Exclusion Criteria:

- Currently receiving parenteral feeding; presence of a nasogastric or other enteral
tube for feeding or decompression.

- History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker
placement, vagotomy, bariatric procedure.

- History of pyloric injection of botulinum toxin within 6 months of screening.

- Persistent daily vomiting.

- Patients with clinical suspicion of upper gastrointestinal obstruction must have been
evaluated per standard of care, and obstruction ruled out before screening.

- Currently taking opiates.

- Currently taking GLP-1 and amylin analogs.

- Allergic or intolerant of egg, wheat, milk or algae, as these are components of the
GEBT study meal.

- History of anorexia nervosa, binge-eating or bulimia within 5 years.

- ALT or AST > 1.5 X upper limit of normal during screening.

- History of intestinal malabsorption or pancreatic exocrine disease.

- Requires hemodialysis or has end-stage renal disease.

- History of human immunodeficiency virus (HIV) infection.

- Clinically significant neurologic or psychiatric disorders which are likely to impact
compliance with protocol requirements.

- Poor venous access or inability to tolerate venipuncture.

- Participation in a clinical study within the 30 days prior to dosing in the present
study.

- Any other reason, which in the opinion of the Investigator, including renal, hepatic
or cardiopulmonary disease, or significant acute ECG abnormalities that would
confound proper interpretation of the study or expose a patient to unacceptable risk.