Diabetic Gastroparesis Study 05 | NCT03786380

ID	Type	Description	Link
2019-000406-30	EudraCT Number

Label	Type	Description	Intervention Names
Relamorelin 10 μg	Experimental	Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months.	Drug: Relamorelin 10 μg

Name	Type	Description	Arm Group Labels	Other Names
Relamorelin 10 μg	Drug	Relamorelin 10 μg injected subcutaneously twice daily.	Relamorelin 10 μg

Outcomes Module

Primary Outcomes

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

Eligibility Module

Name	Affiliation	Role
Harvy Schneier	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pinnacle Research Group		Anniston	Alabama	36207	United States
North Alabama Research Center, LLC

ID	Title	Description
FG000	Relamorelin/Relamorelin/Relamorelin	Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week randomized withdrawal period (RWP) of RLM-MD-03.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 12, 2021	Nov 19, 2021

Arm/Group Information

ID	Title	Description
BG000	Relamorelin/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
BG001	Relamorelin/Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
BG002	Placebo/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
BG003	Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
BG004	Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
BG005	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Safety Population included all participants who received ≥1 administration of study treatment.

Posted

Count of Participants

Participants

Up to approximately 22 months

ID	Title	Description
OG000	Relamorelin/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
OG001	Relamorelin/Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
OG002	Placebo/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
OG003	Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
OG004	Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.

Units	Counts
Participants	OG00035 OG00122 OG00254 OG003

Title

Denominators

Categories

Title	Measurements
	OG00016 OG00111 OG00227 OG003

Primary

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.

Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS baseline values and at least one post-baseline assessment.

Posted

Count of Participants

Participants

Baseline (Day 1) up to approximately 22 months

ID	Title	Description
OG000	Relamorelin/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
OG001	Relamorelin/Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
OG002

Primary

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.

Safety Population included all participants who received ≥1 administration of study treatment.

Posted

Count of Participants

Participants

Up to approximately 22 months

ID	Title	Description
OG000	Relamorelin/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
OG001	Relamorelin/Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
OG002	Placebo/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.

Primary

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.

Safety Population included all participants who received ≥1 administration of study treatment.

Posted

Count of Participants

Participants

Up to approximately 22 months

ID	Title	Description
OG000	Relamorelin/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
OG001	Relamorelin/Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
OG002	Placebo/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Relamorelin/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.	35	2	35	10	35
EG001	Relamorelin/Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.	22	3	22	6	22
EG002	Placebo/Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.	54	7	54	15	54
EG003	Relamorelin/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.	63	2	62	10	62
EG004	Placebo/Relamorelin	Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.	28	0	28	7	28

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG0030 affected62 at risk EG0040 affected28 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0022 affected54 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Pneumonia	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0022 affected54 at risk EG003
Cellulitis	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Influenza	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG003
Urosepsis	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG003
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 23.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 23.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Spinal claudication	Nervous system disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG003
Syncope	Nervous system disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Thalamic infarction	Nervous system disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected22 at risk EG0020 affected54 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment		EG0003 affected35 at risk EG0010 affected22 at risk EG0022 affected54 at risk EG0035 affected62 at risk EG0043 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA: 23.1	Systematic Assessment		EG0002 affected35 at risk EG0013 affected22 at risk EG0022 affected54 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA: 23.1	Systematic Assessment	Number at risk is based on the female population.	EG0000 affected26 at risk EG0011 affected14 at risk EG0020 affected38 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA: 23.1	Systematic Assessment		EG0002 affected35 at risk EG0010 affected22 at risk EG0021 affected54 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment		EG0001 affected35 at risk EG0012 affected22 at risk EG0022 affected54 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment		EG0002 affected35 at risk EG0010 affected22 at risk EG0020 affected54 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA: 23.1	Systematic Assessment		EG0002 affected35 at risk EG0010 affected22 at risk EG0022 affected54 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA: 23.1	Systematic Assessment		EG0000 affected35 at risk EG0011 affected22 at risk EG0023 affected54 at risk EG003
Headache	Nervous system disorders	MedDRA: 23.1	Systematic Assessment		EG0001 affected35 at risk EG0010 affected22 at risk EG0024 affected54 at risk EG003

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010243	Paralysis
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms