A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03420781
• Collaborator: (none)
• Enrollment: 467
• Locations: 337
• Arms: 5
• Actual Duration (Months): 33.2
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis; Diabetes Mellitus	Drug: Placebo; Drug: Relamorelin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 467 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
• Actual Study Start Date: Jan 24, 2018
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Treatment Period: Placebo Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Drug: Placebo; Placebo injected twice daily
Experimental: Treatment Period: Relamorelin 10 μg Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.	Drug: Relamorelin; Relamorelin 10 μg injected twice daily
Experimental: Randomized Withdrawal Period: Placebo then Relamorelin 10 μg Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.	Drug: Placebo; Placebo injected twice daily; Drug: Relamorelin; Relamorelin 10 μg injected twice daily
Experimental: Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Drug: Relamorelin; Relamorelin 10 μg injected twice daily
Experimental: Randomized Withdrawal Period: Relamorelin 10 μg then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Drug: Placebo; Placebo injected twice daily; Drug: Relamorelin; Relamorelin 10 μg injected twice daily

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study]

   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 in the previous studies.

2. Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period [Week 6 to Week 12]

   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 first 12-weeks of the 40-week Treatment Period.

Secondary Outcome Measures

1. Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)]

   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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

2. Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)]

   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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

3. Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)]

   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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

4. Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)]

   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 first 12-weeks of the 40-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). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

5. Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)]

   Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) 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 of the previous studies.

6. Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period [Week 37 to Week 40]

   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 the last 4 weeks of the 40-week Treatment Period.

7. Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)]

   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. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

8. Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)]

   Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an 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). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

9. Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)]

   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. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

10. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)]

    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.

11. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [Up to 46 weeks]

    Clinical Laboratory values 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.

12. Number of Participants With Clinically Meaningful Trends for Vital Signs [Up to 46 weeks]

    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.

13. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [Up to 46 weeks]

    A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

14. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [Up to 46 weeks]

15. Number of Participants With Anti-relamorelin Antibody Testing Results [Up to 46 weeks]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants are eligible to be included in the study only if all the following criteria apply:

• Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study

• Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures

• In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

• Participants are excluded from the study if any of the following criteria apply:

• Participant is not willing or able to abide by the restrictions regarding concomitant medicine use

• Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03

• Participant has an unresolved adverse event (AE) or 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Alabama Research Center, LLC	Athens	Alabama	United States	35611
2	Digestive Health Specialist of the South East	Dothan	Alabama	United States	36305
3	G & L Research, LLC	Foley	Alabama	United States	36535
4	Alabama Medical Group, PC	Mobile	Alabama	United States	36608
5	Del Sol Research Management, LLC	Chandler	Arizona	United States	85224
6	Phoenix Clinical LLC.	Phoenix	Arizona	United States	85014
7	Del Sol Research Management, LLC	Tucson	Arizona	United States	85712
8	Preferred Research Partners, Inc.	Little Rock	Arkansas	United States	72211
9	Applied Research Center of Arkansas	Little Rock	Arkansas	United States	72212
10	Arkansas Gastroenterology	North Little Rock	Arkansas	United States	72117
11	Unity Health - Searcy Medical Center	Searcy	Arkansas	United States	72143
12	Hope Clinical Research	Canoga Park	California	United States	91303
13	GW Research Inc	Chula Vista	California	United States	91910
14	Kindred Medical Institute for Clinical Trials, LLC	Corona	California	United States	92879
15	Aurora Care Clinic, LLC	Costa Mesa	California	United States	92627
16	Diagnamics Inc.	Encinitas	California	United States	92024
17	VVCRD Research	Garden Grove	California	United States	92845
18	University of California San Diego	La Jolla	California	United States	92037
19	Om Research LLC	Lancaster	California	United States	93534
20	Torrance Clinical Research Institute, Inc.	Lomita	California	United States	90717
21	Angel City Research Inc.	Los Angeles	California	United States	90026
22	TriWest Research Associates	Poway	California	United States	92064
23	Medical Associates Research Group, Inc	San Diego	California	United States	92123
24	Syrentis Clinical Research	Santa Ana	California	United States	92705
25	Upland Clinical Research	Upland	California	United States	91786
26	Peak Gastroenterology Associates	Colorado Springs	Colorado	United States	80907
27	Synexus Clinical Research US, Inc. - Colorado Springs Family Practice	Colorado Springs	Colorado	United States	80909
28	Gastroenterology Associates of Fairfield County, P.C.	Bridgeport	Connecticut	United States	06606
29	TrialSpark, Inc.	Washington	District of Columbia	United States	20017
30	Innovative Research of West FL, Inc.	Clearwater	Florida	United States	33756
31	West Central Gastroenterology	Clearwater	Florida	United States	33756
32	Clinical Research of West Florida	Clearwater	Florida	United States	33765
33	ALL Medical Research LLC	Cooper City	Florida	United States	33024
34	Top Medical Research	Cutler Bay	Florida	United States	33189
35	Palmetto Research, LLC	Hialeah	Florida	United States	33016
36	Vida Clinical Trials	Homestead	Florida	United States	33030
37	Nature Coast Clinical Research	Inverness	Florida	United States	34452
38	Panax Clinical Research, LLC.	Miami Lakes	Florida	United States	33014
39	Savin Medical Group LLC	Miami Lakes	Florida	United States	33014
40	APF Research LLC	Miami	Florida	United States	33134
41	AMPM Research Clinic	Miami	Florida	United States	33169
42	Advanced Medical Research Institute	Miami	Florida	United States	33174
43	Florida Research Center, Inc.	Miami	Florida	United States	33174
44	American Research Institute, Inc	Miami	Florida	United States	33175
45	Synexus	Pinellas Park	Florida	United States	33781
46	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
47	Emory University	Atlanta	Georgia	United States	30322
48	River Birch Research Alliance, LLC	Blue Ridge	Georgia	United States	30513
49	Gwinnett Research Institute, LLC	Buford	Georgia	United States	30519
50	Summit Clinical Research, LLC.	Carnesville	Georgia	United States	30521
51	iResearch Atlanta LLC	Decatur	Georgia	United States	30030
52	Infinite Clinical Trials	Riverdale	Georgia	United States	30274
53	Clinical Research Consultants of Atlanta	Suwanee	Georgia	United States	30024
54	Rocky Mountain Diabetes and Osteoporosis Center, PA	Idaho Falls	Idaho	United States	83404-7596
55	Southwest Gastroenterology	Oak Lawn	Illinois	United States	60453
56	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
57	American Research, LLC	Jeffersonville	Indiana	United States	47130
58	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
59	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
60	Health Science Research Center	Pratt	Kansas	United States	67124
61	WestGlen Gastrointestinal Consultants	Shawnee Mission	Kansas	United States	67214
62	Cotton-O'Neil Clinical Research Center - Digestive Health	Topeka	Kansas	United States	66606
63	Kansas Medical Clinic	Topeka	Kansas	United States	66606
64	Professional Research Network of Kansas, LLC	Wichita	Kansas	United States	67205
65	Via Christi Clinic, PA	Wichita	Kansas	United States	67208
66	Tri-State Gastroenterology	Crestview Hills	Kentucky	United States	41017
67	University of Louisville	Louisville	Kentucky	United States	40202
68	Delta Research Partners	Bastrop	Louisiana	United States	71220
69	WK Physicians Network	Bossier City	Louisiana	United States	71111
70	Avant Research Associates LLC	Crowley	Louisiana	United States	70526
71	Cronola LLC	Houma	Louisiana	United States	70360
72	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana	United States	70601
73	Tandem Clinical Research	Marrero	Louisiana	United States	70072
74	New Orleans Research Institute - Metropolitan Gastroenterology Associates	Metairie	Louisiana	United States	70006
75	Clinical Trials of America, Inc.	West Monroe	Louisiana	United States	71291
76	Trialspark - Silverman	Bowie	Maryland	United States	20716
77	Gastro Center of Maryland	Columbia	Maryland	United States	21045
78	Frederick Gastroenterology Associates, PA an Elligo Health Research Site	Frederick	Maryland	United States	21701
79	Woodholme Gastroenterology Associates, P.A.	Glen Burnie	Maryland	United States	21061
80	Meridian Clinical Research, LLC	Rockville	Maryland	United States	20854
81	Commonwealth Clinical Studies, PLLC.	Brockton	Massachusetts	United States	02302
82	Clinical Research Institute of Michigan	Chesterfield	Michigan	United States	48047
83	Vida Clinical Studies	Dearborn	Michigan	United States	48124
84	Aa Mrc Llc	Flint	Michigan	United States	48504
85	National Clinical, LLC	Hamtramck	Michigan	United States	48212
86	Gastroenterology Associates of Western Michigan	Wyoming	Michigan	United States	49519
87	Minnesota Gastroenterology, P.A.	Coon Rapids	Minnesota	United States	55446
88	Montana Medical Research	Missoula	Montana	United States	59808
89	Methodist Physicians Clinic Diabetes and Endocrine Specialists	Omaha	Nebraska	United States	68114
90	Heartland Clinical Research, Inc	Omaha	Nebraska	United States	68134
91	Excel Clinical Research	Las Vegas	Nevada	United States	89109
92	Clinical Research of South Nevada	Las Vegas	Nevada	United States	89121
93	Advanced Biomedical Research of America	Las Vegas	Nevada	United States	89123
94	Digestive Disease Specialists	Las Vegas	Nevada	United States	89128
95	Palm Research Center	Las Vegas	Nevada	United States	89148
96	Garden State Endocrinology	Brick	New Jersey	United States	08723
97	AGA Clinical Research Associates LLC	Egg Harbor Township	New Jersey	United States	08234
98	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico	United States	87108
99	Long Island Gastrointestinal Research Group LLP	Great Neck	New York	United States	11023
100	Synexus Clinical Research US, Inc.	Jamaica	New York	United States	11432
101	United Health Services Hospitals, Inc.	Johnson City	New York	United States	13790
102	Asheville Gastroenterology Associates	Asheville	North Carolina	United States	28801
103	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7080
104	Carolina Digestive Health Associates, PA	Concord	North Carolina	United States	28025
105	Cumberland Research Associates, LLC	Fayetteville	North Carolina	United States	28304
106	Triad Clinical Trials	Greensboro	North Carolina	United States	27410
107	Vidant Multispeciality Clinic - Kinston	Kinston	North Carolina	United States	28501
108	Diabetes and Endocrinology Consultants, PC	Morehead City	North Carolina	United States	28557
109	PMG Research Salisbury	Salisbury	North Carolina	United States	28144
110	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
111	Trial Management Associates, LLC	Wilmington	North Carolina	United States	28403
112	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
113	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
114	Dayton Gastroenterology, Inc.	Beavercreek	Ohio	United States	45440
115	Diabetes & Endocrinology Associates of Stark County, Inc.	Canton	Ohio	United States	44718
116	Synexus Clinical Research US - Cincinnati	Cincinnati	Ohio	United States	45236
117	Endocrinology Research Associates, Inc.	Columbus	Ohio	United States	43201
118	The Ohio State University, Wexner Medical Center	Columbus	Ohio	United States	43203
119	Aventiv Research, Inc.	Columbus	Ohio	United States	43213
120	Hometown Urgent Care and Research	Columbus	Ohio	United States	43214
121	CIC America Clinical Inquest Center Ltd.	Dayton	Ohio	United States	45409
122	Hometown Urgent Care and Research	Dayton	Ohio	United States	45424
123	Premier Clinical Research d.b.a. STAT Research	Franklin	Ohio	United States	45005
124	Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research	Wadsworth	Ohio	United States	44281
125	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma	United States	73112
126	Memorial Clinical Research	Oklahoma City	Oklahoma	United States	73120
127	Options Health Research, LLC	Tulsa	Oklahoma	United States	74104
128	Northwest Gastroenterology Clinic, LLC	Portland	Oregon	United States	97210
129	Family Medical Associates, Research Department	Levittown	Pennsylvania	United States	19056
130	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania	United States	15212
131	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania	United States	15236
132	Frontier Clinical Research, LLC	Smithfield	Pennsylvania	United States	15478
133	Montgomery Medical, Inc.	Smithfield	Pennsylvania	United States	15478
134	Preferred Primary Care Physicians	Uniontown	Pennsylvania	United States	15401
135	Synexus Clinical Research US, Inc.	Anderson	South Carolina	United States	29621
136	Synexus Clinical Research US, Inc	Anderson	South Carolina	United States	29621
137	Clinical Trials of South Carolina	Charleston	South Carolina	United States	29406
138	Gastroenterology Associates, PA	Greenville	South Carolina	United States	29615
139	Health Concepts	Rapid City	South Dakota	United States	57702
140	Clinsearch	Chattanooga	Tennessee	United States	37421
141	Gastro One	Germantown	Tennessee	United States	38138
142	Quality Medical Research	Nashville	Tennessee	United States	37211
143	Texas Clinical Research Institute, LLC	Arlington	Texas	United States	76012
144	Avant Research Associates,LLC	Austin	Texas	United States	78704
145	ClinRx Research, LLC	Carrollton	Texas	United States	75007
146	Synexus Clinical Research US, Inc.	Dallas	Texas	United States	75234
147	Biopharma Informatic Inc., Research Center	Houston	Texas	United States	77043
148	Rodriguez Clinical Trials	Houston	Texas	United States	77083
149	Amir Ali Hassan, MD, PA	Houston	Texas	United States	77089
150	Sante Clinical Research	Kerrville	Texas	United States	78028
151	Pinnacle Clinical Research	San Antonio	Texas	United States	78215
152	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
153	Southern Star Research Institute, LLC	San Antonio	Texas	United States	78229
154	Synexus Clinical Research US, Inc.	San Antonio	Texas	United States	78229
155	Advanced Research Institute, Inc.	Ogden	Utah	United States	84405
156	Advanced Clinical Research	West Jordan	Utah	United States	84088
157	Verity Research Inc.	Fairfax	Virginia	United States	22031
158	Manassas Clinical Research Centre	Manassas	Virginia	United States	20110
159	Cardinal Internal Medicine Associates, PC	Woodbridge	Virginia	United States	22192
160	Washington Gastroenterology PLLC	Tacoma	Washington	United States	98405
161	West Virginia University	Morgantown	West Virginia	United States	26506
162	Maffei Centro Medico-Investigacion Clinica Aplicada	C.a.b.a.	Buenos Aires Province	Argentina	C1425AGC
163	Hospital Sirio Libanes	Caba	Buenos Aires Province	Argentina	C1419AHN
164	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Buenos Aires Province	Argentina	B7600FYK
165	Instituto Privado de Investigaciones Clínicas de Córdoba	Córdoba	Cordoba	Argentina	X5000AAW
166	Instituto de Investigaciones Clinicas de Rosario	Rosario	Santa Fe	Argentina	2000
167	Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli	Rosario	Santa Fe	Argentina	S200CFK
168	Clinica Mayo de Urgencias Medicas Cruz Blanca SRL	San Miguel de Tucuman	Tucuman	Argentina	4000
169	CIPREC	Ciudad Autonoma de Buenos Aires		Argentina	1119
170	Centro Universitario de Investigacion en Farmacologia Clinic	Corrientes		Argentina	W3410AVV
171	Nepean Hospital	Kingswood	New South Wales	Australia	2747
172	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
173	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
174	Ordination	Sankt Stefan ob Stainz	Styria	Austria	8511
175	VIVIT Institute, am LKH Feldkirch	Feldkirch'	Vorarlberg	Austria	6807
176	Privatklinik Wehrle-Diakonissen	Salzburg		Austria	5020
177	Landeskrankenhaus Steyr	Steyr		Austria	4400
178	Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,	Edegem	Antwerp	Belgium	2650
179	UZ Brussel	Jette	Brussel	Belgium	1090
180	AZ Sint Lucas Brugge	Brugge	West-Vlaanderen	Belgium	8310
181	Hospital Universitário Walter Cantídio	Fortaleza	Ceara	Brazil	60430-370
182	Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology	Fortaleza	Ceará	Brazil	60160-230
183	Centro de Pesquisa Clinica do Brasil	Brasilia	Distrito Federal	Brazil	71625175
184	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul	Brazil	90430-001
185	Instituto Catarinense de Endocrinologia e Diabetes (ICED)	Joinville	Santa Catarina	Brazil	89201-260
186	Scentryphar Pesquisa Clinica Ltda	Campinas	Sao Paulo	Brazil	13020-431
187	Instituto de Pesquisa Clinica de Campinas	Campinas	Sao Paulo	Brazil	13060904
188	CPQuali Pesquisa Clinica Ltda	Santa Cecília	São Paulo	Brazil	01228-000
189	Hospital Universitário João de Barros Barreto	Belém		Brazil	66073-000
190	IPEC-Instituto de Pesquisa Clinica	Sao Paulo		Brazil	01223-001
191	MHAT Yuliya Vrevska Byala	Byala	Ruse	Bulgaria	7100
192	UMHAT - Kaspela- EOOD	Plovdiv		Bulgaria	4002
193	University of Calgary	Calgary	Alberta	Canada	T2N 2T9
194	Alberta Diabetes Institute	Edmonton	Alberta	Canada	T6G 2E1
195	Central Alberta Research Centre	Red Deer	Alberta	Canada	T4N 6V7
196	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
197	South Shore Medical Arts	Bridgewater	Nova Scotia	Canada	B4V 2V6
198	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 7W9
199	Toronto Digestive Disease Associates	Vaughan	Ontario	Canada	L4L 4YZ
200	Recherche GCP Research	Montreal	Quebec	Canada	H1M 1B1
201	Centro Cardiovascular Colombiano Clínica Santa María	Medellin	Antioquia	Colombia	050034
202	Rodrigo Botero S.A.S.	Medellín	Antioquia	Colombia	050030
203	Centro Cardiovascular y de Diabetes	Barranquilla	Atlantico	Colombia	080020
204	Fundacion BIOS	Barranquilla	Atlantico	Colombia	080020
205	Endocare Ltda.	Bogotá	Cundinamarca	Colombia	111111
206	Healthy Medical Center	Zipaquirá	Cundinamarca	Colombia	250252
207	Medplus Medicina Prepagada	Bogota	Distrito Capital De Bogota	Colombia	110221
208	Asociación Colombiana de Diabetes	Teusaquillo	Distrito Capital De Bogotá	Colombia	111311
209	Fundacion Centro de Investigaciones Clinicas CARDIOMET	Pereira	Risaralda	Colombia	660002
210	Centro Medico Imbanaco de Cali S.A.	Cali	Valle Del Cauca	Colombia	760001
211	IPS Centro Medico Julian Coronel S.A	Cali	Valle Del Cauca	Colombia	760035
212	Gentofte Hospital	Hellerup	Copenhagen	Denmark	2900
213	Gastroenheden, Hvidovre hospital	Hvidovre	Copenhagen	Denmark	2650
214	Klinische Forschung Karlsruhe GmbH	Karlsruhe	Baden-Wuertemberg	Germany	76137
215	Studienzentrum Schwittay	Böhlen	Saxony	Germany	4564
216	Klinische Forschung Dresden GmbH	Dresden	Saxony	Germany	1309
217	Clinical Research Hamburg	Hamburg		Germany	22143
218	Israelitisches Krankenhaus	Hamburg		Germany	22297
219	KRH Klinikum Siloah	Hannover		Germany	30459
220	First Department of Medicine, University of Szeged	Szeged	Csonfrád	Hungary	6720
221	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger	Heves	Hungary	H-3300
222	Hetenyi Geza Hospital	Tószeg	Jász-Nagykun-Szolnok	Hungary	H-5004
223	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Zala	Hungary	H-8900
224	Synexus Budapest DRS	Budapest		Hungary	1036
225	Strázsahegy Gyógyszertár Medicina	Budapest		Hungary	H1171
226	Kumudini Devi Diabetes Research Center; Ramdevrao Hospital	Hyderabad	Andhra Pradesh	India	500072
227	King George Hospital	Visakhapatnam	Andhra Pradesh	India	530002
228	Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre	Ahmedabad	Gujarat	India	380007
229	Victoria Hospital	Bangalore	Karnataka	India	560002
230	Life Care Hospital & Research Centre	Bangalore	Karnataka	India	560092
231	Diacon Hospital and research Center - Diabetology	Bengaluru	Karnataka	India	359-360
232	Rajalakshmi Hospital	Bengaluru	Karnataka	India	560097
233	Vinaya Hospital & Research Centre	Mangalore	Karnataka	India	575003
234	Bhatia Hospital	Mumbai	Maharashtra	India	400007
235	B. J. Government Medical College and Sassoon General Hospitals	Pune	Maharashtra	India	411001
236	Universal Hospital	Pune	Maharashtra	India	411011
237	Noble Hospital	Pune	Maharashtra	India	411013
238	S.R. Kalla (SRK) Memorial Gastro & General Hospital	Jaipur	Rajasthan	India	302001
239	Diabetic Thyroid and Endocrine Centre	Jaipur	Rajasthan	India	302006
240	Marudhar Hospital	Jaipur	Rajasthan	India	302012
241	Eternal Hospital - Diabetology	Jaipur	Rajasthan	India	302017
242	SMS Hospital	Jaipur	Rajasthan	India	302017
243	Kovai Diabetes Speciality Centre	Coimbatore	Tamil Nadu	India	641009
244	Arthur Asirvatham Hospital	Madurai	Tamil Nadu	India	625020
245	M. V Hospital & Research Centre	Lucknow	Uttar Prandesh	India	226003
246	Sir Ganga Ram Hospital	New Delhi		India	110060
247	Bnai Zion Medical Center	Haifa		Israel	31048
248	Endocrinology & Diabetes Center	Safed		Israel	13100
249	Chonbuk National University Hospital	Jeonju	Jeollabuk-Do	Korea, Republic of	561-712
250	Diabetes Center	Seoul	Nowon-gu	Korea, Republic of	01757
251	Asan Medical Center	Seoul		Korea, Republic of	05505
252	Kraslava Hospital	Kraslava	Kraslavas Nov.	Latvia	5601
253	Polana-D	Daugavpils		Latvia	LV5401
254	Pauls Stradins Clinical University Hospital, Endokrinologijas nodala	Riga		Latvia	1002
255	Digestive Diseases Centre GASTRO	Riga		Latvia	1006
256	Hospital Sultanah Bahiyah	Alor Setar	Kedah	Malaysia	5460
257	Universiti Sains Malaysia	Kubang Kerian		Malaysia	16150
258	Hospital Taiping	Taiping		Malaysia	34000
259	Mentrials SA DE CV	Cuauhtemoc	Cdmx	Mexico	06700
260	Clinicos Asociados BOCM SC	Mexico	Distrito Federal	Mexico	03300
261	Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology	Mexico	Distrito Federal	Mexico	11650
262	Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición	Durango	Guillermina	Mexico	34270
263	Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.	Guadalajara	Jalisco	Mexico	44150
264	Consultorio Medico	Guadalajara	Jalisco	Mexico	C.P. 44210
265	Unidad de Investigación Clínica en Medicina S.C.	Guadalajara	Jalisco	Mexico	C.P. 44670
266	Centro de Atención e Investigación en Factores de Riesgo Car	Mexico	Mexico DF	Mexico	14000
267	Centro de Desarrollo Biomédico S.C.P	Mérida	Yucatán	Mexico	97070
268	Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV	Aguascalientes		Mexico	20230
269	Hospital Cardiologica Aguascalientes	Aguascalientes		Mexico	20230
270	Dioderm Instituto de Investigacion	Durango		Mexico	34060
271	Sociedad de Metabolismo y Corazon, S.C.	Veracruz		Mexico	91900
272	West Visayas State University Medical Center	IloIlo City	IloIlo	Philippines	5000
273	St. Luke's Medical Center	Quezon City	Metro Manila	Philippines	1100
274	Cardinal Santos Medical Center	San Juan City	Metro Manila	Philippines	1502
275	Manila Doctors Hospital, Ermita	Manila	Metropolitan Manila	Philippines	1000
276	San Juan De Dios Educational Foundation, Inc.	Pasay	Metropolitan Manila	Philippines	1300
277	Ospital ng Makati	Makati City	NCR	Philippines	1218
278	Perpetual Succor Hospital	Cebu City		Philippines	6000
279	NZOZ Vita Diabetica - Malgorzata Buraczyk	Bialystok	Podlaski	Poland	15-798
280	Endoskopia Sp. Z O.O.	Sopot	Pomorskie	Poland	81-756
281	Centrum Medyczne Lukamed	Chojnice		Poland	89-600
282	Specjalistyczny Gabinet Neurologiczny Marta Banach	Krakow		Poland	30-539
283	Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska	Wroclaw		Poland	51-162
284	Saint-Petersburg City Pokrovskaya Hospital	St-Petersburg	Leningrad Region	Russian Federation	199106
285	Scientific Institute of Clinical and Experimental Lymphology	Novosibirsk	Novosibirskaya Oblast	Russian Federation	630117
286	North-Western State Medical University named after I. I. Mechnikov	Saint-Petersburg	Sankt-Peterburg	Russian Federation	191015
287	Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko	Nizhny Novgorod	Volga	Russian Federation	603126
288	Kazan State Medical University	Kazan		Russian Federation	420100
289	FSBI National medical endocrinology research centre	Moscow		Russian Federation	117036
290	Moscow Regional Research Clinical Institute named by MF Vladimirski	Moscow		Russian Federation	129110
291	Rostov on Don	Rostov on Don		Russian Federation	344019
292	Rostov State Medical University	Rostov-on-Don		Russian Federation	344022
293	GUZ Saratov City Clinical Hospital 9	Saratov		Russian Federation	410030
294	Saratov City Clinical Hospital 12	Saratov		Russian Federation	410039
295	National University Hospital	Singapore		Singapore	119228
296	Singapore General Hospital	Singapore		Singapore	169856
297	Changi General Hospital	Singapore		Singapore	529889
298	FARMOVS	Bloemfontein	Free State	South Africa	9301
299	Wits Clinical Research	Johannesburg	Gauteng	South Africa	2193
300	Synexus Stanza Clincal Reaserch Centre	Pretoria	Gauteng	South Africa	0122
301	Watermeyer Clinical Research Site	Pretoria	Gauteng	South Africa	0184
302	Synexus Helderberg Clinical Research Centre	Cape Town	Western Cape	South Africa	7130
303	Phramongkutklao Hospital	Bangkok		Thailand	10400
304	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok		Thailand	10700
305	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai		Thailand	50200
306	Ivano-Frankivsk National Medical University	Ivano-Frankivsk	Ivano-Frankivsk Oblast	Ukraine	76008
307	Ivano-Frankivsk Central City Clinical Hospital	Ivano-Frankivsk	Ivano-Frankivsk Oblast	Ukraine	76018
308	Regional muniRegional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious	Chernivtsi		Ukraine	58001
309	Regional Public Organization "Chernivtsi Regional Endocrinology Center"	Chernivtsi		Ukraine	58022
310	State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine	Dnipro		Ukraine	49027
311	Municipal nonprofit entity of Kharkiv municipal council	Kharkiv		Ukraine	61037
312	L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine	Kharkiv		Ukraine	61039
313	Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"	Kharkiv		Ukraine	61070
314	Communal Institution Kherson City Clinical Hospital	Kherson		Ukraine	73000
315	Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv	Kyiv		Ukraine	2002
316	Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"	Kyiv		Ukraine	3049
317	Medical Center Universal Clinic Oberig	Kyiv		Ukraine	3057
318	Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit	Kyiv		Ukraine	4050
319	Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University	Odesa		Ukraine	65010
320	Communal Institution "Odesa Regional Clinical Hospital", Out-patient department	Odesa		Ukraine	65025
321	Poltava Regional Clinical Hospital	Poltava		Ukraine	36011
322	Ternopil University Hospital	Ternopil		Ukraine	46000
323	Private Small-Scale Enterprise Medical Centre Pulse	Vinnytsia		Ukraine	21001
324	Vinnytsia Regional Clinical highly specialized Endocrinology Centre	Vinnytsia		Ukraine	21010
325	Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia	Vinnytsia		Ukraine	21029
326	6th City Clinical Hospital, c. Zaporizhzhia	Zaporizhzhia		Ukraine	69035
327	Municipal Institution, City Hospital #7	Zaporizhzhia		Ukraine	69600
328	Biomedical Research Centre	Nottingham	East Midland	United Kingdom	NG7 2UH
329	MAC Clinical Research Manchester	Manchester	Greater Manchester	United Kingdom	M13 9NQ
330	Royal Oldham Hospital	Oldham	Lancashire	United Kingdom	OL1 2JH
331	MAC Research, Exchange House	Cannock	Staffordshire	United Kingdom	WS11 0BH
332	MAC Clinical Research, Monarch House	Leeds	West Yorkshire	United Kingdom	LS10 1DU
333	MAC Research	Barnsley		United Kingdom	S75 3DL
334	MAC Clinical Research, Kaman Court	Blackpool		United Kingdom	FY2 0JH
335	Mid Essex Hospital Services NHS Trust Broomfield Hospital	Chelmsford		United Kingdom	CM1 7ET
336	MAC Clinical Research	Liverpool		United Kingdom	L34 1BH
337	MAC Clinical Research, GAC House	Stockton-on-Tees		United Kingdom	TS17 6EW

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Wieslaw Bochenek, Allergan

Study Documents (Full-Text)

• Study Protocol - Mar 10, 2021
• Statistical Analysis Plan - Dec 9, 2020

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03420781
• Other Study ID Numbers: RLM-MD-03
• First Posted: Feb 5, 2018
• Last Update Posted: Dec 22, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Allergan: diabetic gastroparesis; vomiting
• Additional relevant MeSH terms: Gastroparesis

Study Results

Participant Flow

Pre-assignment Detail	Participants who completed RLM-MD-01 [NCT03285308] or RLM-MD-02 [NCT03426345] were eligible for enrollment.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Period Title: Treatment Period (40 Weeks)
STARTED	236	231	0	0	0
Safety Population	235	231	0	0	0
COMPLETED	92	105	0	0	0
NOT COMPLETED	144	126	0	0	0
Period Title: Treatment Period (40 Weeks)
STARTED	0	0	91	59	43
COMPLETED	0	0	85	54	38
NOT COMPLETED	0	0	6	5	5

Baseline Characteristics

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg	Total
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Total of all reporting groups
Overall Participants	236	231	467
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.5 (11.11)	56.2 (11.51)	55.9 (11.30)
Sex: Female, Male (Count of Participants)
Female	162 68.6%	166 71.9%	328 70.2%
Male	74 31.4%	65 28.1%	139 29.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	83 35.2%	82 35.5%	165 35.3%
Not Hispanic or Latino	153 64.8%	149 64.5%	302 64.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 1.3%	8 3.5%	11 2.4%
Asian	21 8.9%	18 7.8%	39 8.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	37 15.7%	21 9.1%	58 12.4%
White	175 74.2%	183 79.2%	358 76.7%
More than one race	0 0%	1 0.4%	1 0.2%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
Description	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 in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study

Outcome Measure Data

Analysis Population Description

Modified-intent-to-treat (mITT) Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Baseline	24.9 (5.65)	24.8 (6.28)
Change from Baseline to Week 12	-11.9 (9.43)	-11.2 (9.00)

2. Primary Outcome

Title	Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description	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 first 12-weeks of the 40-week Treatment Period.
Time Frame	Week 6 to Week 12

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Number [percentage of participants]	29.4 12.5%	21.4 9.3%

3. Secondary Outcome

Title	Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description	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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Number [percentage of participants]	46.0 19.5%	43.2 18.7%

4. Secondary Outcome

Title	Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description	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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Number [percentage of participants]	40.4 17.1%	39.7 17.2%

5. Secondary Outcome

Title	Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description	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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Number [percentage of participants]	38.3 16.2%	38.4 16.6%

6. Secondary Outcome

Title	Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description	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 first 12-weeks of the 40-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). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Number [percentage of participants]	36.6 15.5%	36.2 15.7%

7. Secondary Outcome

Title	Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
Description	Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) 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 of the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Baseline	24.9 (5.65)	24.8 (6.28)
Change from Baseline to Week 40	-13.3 (10.22)	-12.3 (9.20)

8. Secondary Outcome

Title	Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
Description	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 the last 4 weeks of the 40-week Treatment Period.
Time Frame	Week 37 to Week 40

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Number [percentage of participants]	19.1 8.1%	18.8 8.1%

9. Secondary Outcome

Title	Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
Description	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. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)

Outcome Measure Data

Analysis Population Description

mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	235	229
Baseline	6.8 (11.09)	7.3 (11.52)
Change from Baseline to Week 40	-1.8 (17.51)	-5.4 (11.87)

10. Secondary Outcome

Title	Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
Description	Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an 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). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)

Outcome Measure Data

Analysis Population Description

RW Population included all participants who were re-randomized or assigned to a treatment of RW Period and received ≥1 administration of study treatment during the RW Period. Overall number analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Arm/Group Title	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Measure Participants	91	58	43
Baseline	25.7 (5.65)	25.7 (6.25)	24.4 (5.47)
Change from Baseline to Week 46	-13.4 (10.45)	-12.5 (9.71)	-12.5 (9.35)

11. Secondary Outcome

Title	Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
Description	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. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)

Outcome Measure Data

Analysis Population Description

RW Population included all participants who were re-randomized or assigned to a treatment of RW Period and received ≥1 administration of study treatment during the RW Period. Overall number analyzed are the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Arm/Group Title	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Measure Participants	91	58	43
Baseline	6.1 (7.01)	9.9 (11.92)	4.2 (4.73)
Change from Baseline to Week 46	-1.8 (18.40)	-7.3 (10.23)	-1.8 (6.12)

12. Secondary Outcome

Title	Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Description	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.
Time Frame	First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)

Outcome Measure Data

Analysis Population Description

Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Measure Participants	235	231	91	59	43
Count of Participants [Participants]	129 54.7%	131 56.7%	18 3.9%	12 NaN	8 NaN

13. Secondary Outcome

Title	Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Description	Clinical Laboratory values 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.
Time Frame	Up to 46 weeks

Outcome Measure Data

Analysis Population Description

Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. Number analyzed is the number of participants with non-PCS Baseline values and at least one postbaseline assessment.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Measure Participants	235	231	91	59	43
Eosinophils Absolute Cell Count [10^9/liter(L)]: >3×Upper Limit of Normal Value (ULN)	2 0.8%	1 0.4%	0 0%	1 NaN	1 NaN
Hematocrit (RATIO): >1.1×ULN	1 0.4%	2 0.9%	2 0.4%	1 NaN	0 NaN
Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)	7 3%	7 3%	4 0.9%	0 NaN	2 NaN
Hemoglobin [grams (g)/L]: <0.9×LLN	13 5.5%	14 6.1%	5 1.1%	1 NaN	4 NaN
Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN	1 0.4%	4 1.7%	0 0%	0 NaN	0 NaN
Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN	2 0.8%	3 1.3%	1 0.2%	0 NaN	0 NaN
Mean Corpuscular Volume (fL): <0.9×LLN	4 1.7%	0 0%	1 0.2%	0 NaN	0 NaN
Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN	0 0%	2 0.9%	2 0.4%	0 NaN	0 NaN
Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN	6 2.5%	4 1.7%	2 0.4%	0 NaN	0 NaN
Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN	0 0%	1 0.4%	0 0%	0 NaN	0 NaN
Platelet Count (Thrombocytes) (10^9/L): <0.5×LLN	1 0.4%	0 0%	0 0%	0 NaN	0 NaN
Red Blood Cell Count (10^12/L): >1.1×ULN	1 0.4%	0 0%	0 0%	0 NaN	0 NaN
Red Blood Cell Count (10^12/L): <0.9×LLN	4 1.7%	8 3.5%	4 0.9%	1 NaN	0 NaN
White Blood Cell Count (10^9/L): <0.7×LLN	2 0.8%	0 0%	0 0%	0 NaN	0 NaN
Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN	2 0.8%	2 0.9%	0 0%	2 NaN	1 NaN
Albumin (g/L): <0.9×LLN	1 0.4%	1 0.4%	1 0.2%	0 NaN	1 NaN
Alkaline Phosphatase (U/L): >=3×ULN	0 0%	3 1.3%	0 0%	0 NaN	0 NaN
Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN	3 1.3%	2 0.9%	0 0%	0 NaN	0 NaN
Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN	3 1.3%	2 0.9%	1 0.2%	1 NaN	0 NaN
Bicarbonate (HCO3) (mmol)/L: >0.9×LLN	6 2.5%	9 3.9%	2 0.4%	4 NaN	1 NaN
Bilirubin, Total [micromoles(μmol)/L]: >1.5×ULN	1 0.4%	0 0%	0 0%	0 NaN	0 NaN
Blood Urea Nitrogen (mmol/L): >1.2×ULN	29 12.3%	20 8.7%	8 1.7%	4 NaN	4 NaN
Calcium (mmol/L): >1.1×ULN	1 0.4%	0 0%	1 0.2%	0 NaN	0 NaN
Calcium (mmol/L): <0.9×LLN	1 0.4%	0 0%	0 0%	0 NaN	1 NaN
Chloride (mmol/L): <0.9×LLN	2 0.8%	1 0.4%	1 0.2%	0 NaN	1 NaN
Cholesterol, Total, Fasting (mmol/L): >1.6×ULN	4 1.7%	1 0.4%	0 0%	1 NaN	0 NaN
Creatinine (μmol/L): >1.3×ULN	22 9.3%	16 6.9%	5 1.1%	2 NaN	3 NaN
Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN	41 17.4%	33 14.3%	9 1.9%	9 NaN	4 NaN
Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN	14 5.9%	9 3.9%	4 0.9%	2 NaN	2 NaN
Glycohemoglobin A1C: Increase of >=0.5%	134 56.8%	138 59.7%	62 13.3%	26 NaN	28 NaN
Glycohemoglobin A1C: Increase of >=1%	134 56.8%	138 59.7%	62 13.3%	26 NaN	28 NaN
Phosphorus (mmol/L): >1.1×ULN	10 4.2%	12 5.2%	4 0.9%	4 NaN	4 NaN
Phosphorus (mmol/L): <0.9×LLN	4 1.7%	3 1.3%	0 0%	0 NaN	0 NaN
Potassium (mmol/L): <0.9×LLN	0 0%	0 0%	2 0.4%	0 NaN	0 NaN
Protein, Total (g/L): >1.1×ULN	0 0%	1 0.4%	0 0%	0 NaN	0 NaN
Protein, Total (g/L): <0.9×LLN	0 0%	1 0.4%	0 0%	0 NaN	1 NaN
Triglycerides, Fasting (mmol/L): >=3×ULN	9 3.8%	11 4.8%	4 0.9%	4 NaN	2 NaN
Uric Acid (Urate) (μmol/L): >1.1×ULN	31 13.1%	31 13.4%	5 1.1%	3 NaN	1 NaN
Uric Acid (Urate) (μmol/L): <0.9×LLN	3 1.3%	4 1.7%	1 0.2%	0 NaN	0 NaN

14. Secondary Outcome

Title	Number of Participants With Clinically Meaningful Trends for Vital Signs
Description	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.
Time Frame	Up to 46 weeks

Outcome Measure Data

Analysis Population Description

Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Measure Participants	235	231	91	59	43
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN

15. Secondary Outcome

Title	Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Description	A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time Frame	Up to 46 weeks

Outcome Measure Data

Analysis Population Description

Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Measure Participants	235	231	91	59	43
Count of Participants [Participants]	3 1.3%	2 0.9%	0 0%	0 NaN	0 NaN

16. Secondary Outcome

Title	Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Time Frame	Up to 46 weeks

Outcome Measure Data

Analysis Population Description

Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. Overall number analyzed is the number of participants with non-PCS Baseline values and at least one postbaseline assessment.

Arm/Group Title	Treatment Period: Placebo	Treatment Period: Relamorelin 10 μg	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Measure Participants	224	223	91	59	43
Count of Participants [Participants]	134 56.8%	138 59.7%	62 13.3%	26 NaN	28 NaN

17. Secondary Outcome

Title	Number of Participants With Anti-relamorelin Antibody Testing Results
Description	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.
Time Frame	Up to 46 weeks

Outcome Measure Data

Analysis Population Description

Due to limitations at the vendor's end, the final analysis data could not be obtained.

Arm/Group Title	Treatment Period: Relamorelin 10 μg
Arm/Group Description	Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Measure Participants	0

Adverse Events

Time Frame	First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)
Adverse Event Reporting Description	All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Arm/Group Title	Treatment Period: Placebo		Treatment Period: Relamorelin 10 μg		Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
Arm/Group Description	Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.		Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.		Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.		Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.		Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
All Cause Mortality
	Treatment Period: Placebo		Treatment Period: Relamorelin 10 μg		Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/236 (1.3%)		2/231 (0.9%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Serious Adverse Events
	Treatment Period: Placebo		Treatment Period: Relamorelin 10 μg		Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/235 (10.2%)		20/231 (8.7%)		3/91 (3.3%)		2/59 (3.4%)		1/43 (2.3%)
Cardiac disorders
Coronary artery disease	3/235 (1.3%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Supraventricular extrasystoles	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Cardiac failure congestive	2/235 (0.9%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Acute myocardial infarction	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Atrial fibrillation	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Atrial tachycardia	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Cardiomyopathy	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Myocardial infarction	0/235 (0%)		0/231 (0%)		0/91 (0%)		1/59 (1.7%)		0/43 (0%)
Postinfarction angina	0/235 (0%)		0/231 (0%)		0/91 (0%)		1/59 (1.7%)		0/43 (0%)
Gastrointestinal disorders
Pancreatitis	0/235 (0%)		2/231 (0.9%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Abdominal pain	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Hiatus hernia	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Duodenitis	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Pancreatitis acute	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Vomiting	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Intestinal ischaemia	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
General disorders
Chest pain	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Non-cardiac chest pain	1/235 (0.4%)		0/231 (0%)		1/91 (1.1%)		0/59 (0%)		0/43 (0%)
Infections and infestations
Osteomyelitis	2/235 (0.9%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Pneumonia	1/235 (0.4%)		1/231 (0.4%)		1/91 (1.1%)		0/59 (0%)		0/43 (0%)
Septic shock	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Urinary tract infection	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Abscess limb	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Atypical pneumonia	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
COVID-19	0/235 (0%)		1/231 (0.4%)		1/91 (1.1%)		0/59 (0%)		0/43 (0%)
Cellulitis	0/235 (0%)		1/231 (0.4%)		1/91 (1.1%)		0/59 (0%)		0/43 (0%)
Cellulitis gangrenous	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Diverticulitis	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Localised infection	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Pyelonephritis	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Staphylococcal bacteraemia	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Staphylococcal infection	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Bronchitis	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Gastroenteritis	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Gastroenteritis viral	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Infected dermal cyst	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Pyelonephritis acute	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Renal abscess	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Sepsis	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Upper respiratory tract infection	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Urosepsis	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Injury, poisoning and procedural complications
Chemical poisoning	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Fall	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Rib fracture	0/235 (0%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		1/43 (2.3%)
Investigations
Blood pressure increased	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	2/235 (0.9%)		3/231 (1.3%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Hypoglycaemia	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Hypertriglyceridaemia	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Metabolic acidosis	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		1/43 (2.3%)
Osteoarthritis	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Rotator cuff syndrome	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Pain in extremity	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Nervous system disorders
Cerebrovascular accident	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Transient ischaemic attack	1/235 (0.4%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Hemiparesis	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Hypoaesthesia	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Syncope	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		1/59 (1.7%)		1/43 (2.3%)
Hypertensive encephalopathy	0/235 (0%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		1/43 (2.3%)
Psychiatric disorders
Suicidal ideation	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Confusional state	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Psychogenic tremor	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Renal and urinary disorders
Acute kidney injury	4/235 (1.7%)		3/231 (1.3%)		0/91 (0%)		0/59 (0%)		1/43 (2.3%)
Nephrolithiasis	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Dyspnoea	0/235 (0%)		1/231 (0.4%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Acute respiratory distress syndrome	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Respiratory distress	0/235 (0%)		0/231 (0%)		1/91 (1.1%)		0/59 (0%)		0/43 (0%)
Skin and subcutaneous tissue disorders
Skin ulcer	2/235 (0.9%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Dermatitis	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Vascular disorders
Deep vein thrombosis	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Hypertensive urgency	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Orthostatic hypotension	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Peripheral vascular disorder	1/235 (0.4%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Accelerated hypertension	0/235 (0%)		0/231 (0%)		0/91 (0%)		0/59 (0%)		1/43 (2.3%)
Other (Not Including Serious) Adverse Events
	Treatment Period: Placebo		Treatment Period: Relamorelin 10 μg		Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg		Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/235 (7.7%)		27/231 (11.7%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Infections and infestations
Urinary tract infection	13/235 (5.5%)		16/231 (6.9%)		0/91 (0%)		0/59 (0%)		0/43 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	7/235 (3%)		12/231 (5.2%)		0/91 (0%)		0/59 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.