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

September 21, 2016 updated by: Motus Therapeutics, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • North Little Rock, Arkansas, United States
    • California
      • Concord, California, United States
      • Lomita, California, United States
      • Los Angeles, California, United States
      • Torrance, California, United States
    • Florida
      • Hialeah, Florida, United States
      • Inverness, Florida, United States
      • Miami, Florida, United States
      • West Palm Beach, Florida, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Monroe, Louisiana, United States
    • Maryland
      • Chevy Chase, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Farmington Hills, Michigan, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • North Carolina
      • Morehead City, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Oregon
      • Portland, Oregon, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Germantown, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Lubbock, Texas, United States
    • Virginia
      • Burke, Virginia, United States
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 > 2 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo given subcutaneously for 35 days
Active Comparator: RM-131
Drug: RM-131
Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of RM-131 on gastric emptying time
Time Frame: Screening and Day 28
Change from baseline in gastric half-emptying time (t½)
Screening and Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of RM-131 on symptoms of gastroparesis
Time Frame: Baseline, daily for 28 days, and Day 35
Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary
Baseline, daily for 28 days, and Day 35
Safety and tolerability of RM-131
Time Frame: From Screening through Day 35
Assessment of adverse events and clinical laboratory evaluations
From Screening through Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Motus Therapeutics, Inc.

Investigators

  • Study Director: Chief Development Officer, Rhythm Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-131-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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