A Study to Evaluate the Safety and Effectiveness of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetes Caused Paralysis of the Stomach

Overview

About this study

The purpose of this study is to evaluate the effects of multiple dose regimens of RM-131 on vomiting episodes, stomach emptying and stomach paralysis symptoms in patients with Type 1 and Type 2 diabetes and gastroparesis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Type 1 or type 2 diabetes with stable glycemic control and blood A1c ≤11% at screening
  • Diabetic Gastroparesis, defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain)
  • Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥ 2.6 at least once during the screening period
  • At least 2 vomiting episodes during the ~2 weeks prior to the first screening visit  as ascertained by patient history.
  • Delayed gastric emptying confirmed at screening by abnormal Gastric Emptying Breath Test (GEBT), defined as gastric emptying half-time (t1/2) ≥ 79 minutes (the 80th percentile of normative data)
    • At least 50% of patients enrolled will have a t1/2 ≥ 97 minutes (i.e., the 95th percentile)
  • Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to visit 2
    • daily adjustments of insulin doses are permitted
  • No use of metoclopramide, erythromycin, domperidone, or other GI motility agents, or anti-emetics for at least 2 weeks prior to visit 2, and willingness to remain off these medications (except as used as part of protocol-specific rescue medication) during the course of the clinical trial
  • Body mass index >18 kg/m2
  • If female, has a negative serum or urine pregnancy test and is not 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 1 year since the last menstrual period])
    • Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH)
  • Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures
  • Additional inclusion criteria for randomization after the 2-week single-blind placebo run-in period
    • Compliance with the completion of the DGSSD and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period
    • For those patients whose compliance is measured to be <80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee)
    • At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD

 

Exclusion Criteria

  • Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube [e.g., PEG (percutaneous endoscopic gastrostomy) tube] for feeding or decompression
  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure
    • A history of diagnostic endoscopy is not exclusionary
  • History of pyloric injection of botulinum toxin within 6 months of screening
  • Clinical suspicion of upper gastrointestinal (GI) obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening
  • Currently taking opiates, or expecting to use opiates during the course of the clinical trial
  • Currently taking GLP-1 agonists, SGLT2 inhibitors or pramlintide
  • Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the GEBT study meal. (Gluten-free crackers can be provided)
  • History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN) at visit 1
  • 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 that 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 that, in the Investigator's opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute electrocardiogram (ECG) abnormalities

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Adil Bharucha, M.B.B.S., M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20492237

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