A Safety and Efficacy Study of Relamorelin in Diabetic Ga... | NCT03285308

ID	Type	Description	Link
2017-002136-16	EudraCT Number

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Drug: Placebo
Relamorelin 10 μg	Experimental	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.	Drug: Relamorelin

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo injected subcutaneously twice daily.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)	Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the Run-in Period.	Baseline (Day-14 to Day-1) to Week 12
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.	Week 6 to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea.

Name	Affiliation	Role
Wieslaw (Wes) Bochenek, MD, PhD	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35295	United States
Digestive Health Specialist of the South East

PubMed Identifier	Type	Citation	Retractions
40148033	Derived	Camilleri M, Jencks KJ. Pharmacologic treatments for gastroparesis. Pharmacol Rev. 2025 Mar;77(2):100019. doi: 10.1016/j.pharmr.2024.100019. Epub 2024 Nov 23.

ID	Title	Description
FG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
FG001	Relamorelin 10 μg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 8, 2019	Jul 8, 2021

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

Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)

Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the Run-in Period.

Modified Intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available at the given time-point.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day-14 to Day-1) to Week 12

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants	OG000163 OG001165

Title

Denominators

Categories

Baseline

- ParticipantsOG000163
- ParticipantsOG001165

Title	Measurements
	OG00025.1± 5.53

Primary

Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.

mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.

Posted

Number

percentage of participants

Week 6 to Week 12

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea.

mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.

Posted

Number

percentage of participants

Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary.

mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.

Posted

Number

percentage of participants

Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts

Secondary

Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary.

mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.

Posted

Number

percentage of participants

Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst).

mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.

Posted

Number

percentage of participants

Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts

Secondary

Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)

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 double-blind study treatment.

Posted

Count of Participants

Participants

Up to approximately 16 weeks

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants

Secondary

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 double-blind 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

Up to 12 weeks

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants

Secondary

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 results were clinically significant.

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

Posted

Count of Participants

Participants

Up to 12 weeks

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Abnormal 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 double-blind study treatment.

Posted

Count of Participants

Participants

Up to 12 weeks

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)

HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.

Safety Population included all participants who received ≥1 administration of double-blind 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 12 weeks

ID	Title	Description
OG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
OG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Anti-relamorelin Antibody Testing Results by Visit

A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Safety Population included all participants who received ≥ 1 administration of double-blind study treatment (N=163 in the Relamorelin 10 μg arm). Anti-relamorelin antibody testing was only done for those participants who received treatment with relamorelin. Number analyzed is the number of participants with data available at the given timepoint. Due to a laboratory issue not all positive screening tests were confirmed.

Posted

Count of Participants

Participants

Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

ID	Title	Description
OG000	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Angina pectoris	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0011 affected163 at risk
Angina unstable	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Atrial fibrillation	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Vomiting	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0011 affected163 at risk
Colitis	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Constipation	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Pneumonia	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0003 affected163 at risk EG0012 affected163 at risk
Diverticulitis	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0012 affected163 at risk
Urinary tract infection	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0002 affected163 at risk EG0011 affected163 at risk
Acute sinusitis	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Sepsis	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0002 affected163 at risk EG0010 affected163 at risk
Cystitis	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Pyelonephritis acute	Infections and infestations	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Fall	Injury, poisoning and procedural complications	MedDRA: 23.1	Systematic Assessment	EG0002 affected163 at risk EG0012 affected163 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Vertebral wedging	Musculoskeletal and connective tissue disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Syncope	Nervous system disorders	MedDRA: 23.1	Systematic Assessment	EG0000 affected163 at risk EG0011 affected163 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA: 23.1	Systematic Assessment	EG0002 affected163 at risk EG0011 affected163 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0002 affected163 at risk EG0010 affected163 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk
Hypertension	Vascular disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0011 affected163 at risk
Hypovolaemic shock	Vascular disorders	MedDRA: 23.1	Systematic Assessment	EG0001 affected163 at risk EG0010 affected163 at risk

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
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
BG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	0	167	15	163	9	163
EG001	Relamorelin 10 μg	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.	0	169	16	163	9	163