Diabetic Gastroparesis Study 05

Study Overview
=================
Brief Summary
-----------------
This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.

Official Title
-----------------
Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Drug: Relamorelin 10 μg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful completion of either Study RLM-MD-03 or Study RLM-MD-04 Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator. Exclusion Criteria: Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020 Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease Females who are pregnant, nursing, or planning a pregnancy during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relamorelin 10 μg<br>Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months. | Drug: Relamorelin 10 μg<br>* Relamorelin 10 μg injected subcutaneously twice daily.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug. | Up to approximately 22 months | 
| Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. | Baseline (Day 1) up to approximately 22 months | 
| Number of Participants With Clinically Meaningful Trends for Vital Signs | Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant. | Up to approximately 22 months | 
| Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results | A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant. | Up to approximately 22 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Gastroparesis