Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03426345
• Collaborator: (none)
• Enrollment: 311
• Locations: 240
• Arms: 2
• Actual Duration (Months): 28.9
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 311 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
• Actual Study Start Date: Feb 16, 2018
• Actual Primary Completion Date: Jul 16, 2020
• Actual Study Completion Date: Jul 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Drug: Placebo; Placebo injected subcutaneously twice daily.
Experimental: Relamorelin 10 μg Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.	Drug: Relamorelin; Relamorelin 10 μg injected twice daily for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [Baseline (Day-14 to Day-1) to Week 12]

   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.

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

Secondary Outcome Measures

1. Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) 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 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.

2. Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) 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 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.

3. Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) 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 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.

4. Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) 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 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).

5. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [Up to approximately 16 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.

6. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [Up to 12 weeks]

   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.

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

   Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

8. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [Up to 12 weeks]

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

9. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [Baseline (Day 1) up to 12 weeks]

10. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)]

    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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of Type 1 or Type 2 diabetes mellitus

• Meet the per protocol criteria of diabetic gastroparesis

• Compliance with diary

• Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

• Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube

• Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)

• Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

• History of gastrointestinal disorders that may be similar to gastroparesis

• Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Alabama Research Center, LLC	Athens	Alabama	United States	35611
2	Synexus Clinical Research US - Simon Williamson Clinic	Birmingham	Alabama	United States	35211
3	G & L Research, LLC	Foley	Alabama	United States	36535
4	Alabama Medical Group, PC	Mobile	Alabama	United States	36608
5	Synexus Clinical Research US, Inc.	Tucson	Arizona	United States	85741
6	Applied Research Center of Arkansas	Little Rock	Arkansas	United States	72212
7	Unity Health - Searcy Medical Center	Searcy	Arkansas	United States	72143
8	GW Research Inc.	Chula Vista	California	United States	91910
9	Diagnamics Inc.	Encinitas	California	United States	92024
10	Fresno Clinical Research Center	Fresno	California	United States	93720
11	Torrance Clinical Research Institute, Inc.	Lomita	California	United States	90717
12	Tibor Rubin VA Medical Center	Long Beach	California	United States	90822
13	Angel City Research Inc.	Los Angeles	California	United States	90026
14	Facey Medical Foundation	Mission Hills	California	United States	91345
15	United Medical Doctors	Murrieta	California	United States	92563
16	Stanford Hospital, Digestive Health Clinic	Palo Alto	California	United States	94304
17	TriWest Research Associates	Poway	California	United States	92064
18	Optimal Research California	San Diego	California	United States	92108
19	Syrentis Clinical Research	Santa Ana	California	United States	92705
20	New Hope Research Development	Whittier	California	United States	90603
21	Synexus Clinical Research US, Inc. - Colorado Springs Family Practice	Colorado Springs	Colorado	United States	80909
22	Gastroenterology Associates of Fairfield County, P.C.	Bridgeport	Connecticut	United States	06824
23	Visionary Investigators Network	Aventura	Florida	United States	33180
24	Clinical Research of West Florida	Clearwater	Florida	United States	33765
25	ALL Medical Research LLC	Cooper City	Florida	United States	33024
26	Palmetto Research, LLC	Hialeah	Florida	United States	33016
27	Vida Clinical Trials	Homestead	Florida	United States	33030
28	Sanchez Clinical Research, Inc.	Miami	Florida	United States	33157
29	Gastroenterology Group of Naples	Naples	Florida	United States	34102
30	Synexus	Pinellas Park	Florida	United States	33781
31	Cleveland Clinic Florida - Weston	Weston	Florida	United States	33331
32	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
33	Emory University	Atlanta	Georgia	United States	30322
34	River Birch Research Alliance, LLC	Blue Ridge	Georgia	United States	30513
35	Gwinnett Research Institute, LLC	Buford	Georgia	United States	30519
36	iResearch Atlanta LLC	Decatur	Georgia	United States	30030
37	Clinical Research Consultants of Atlanta	Suwanee	Georgia	United States	30024
38	Rocky Mountain Diabetes and Osteoporosis Center, PA	Idaho Falls	Idaho	United States	83404-7596
39	Synexus Clinical Research US, Inc.	Chicago	Illinois	United States	60602
40	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
41	North Shore University Health System	Evanston	Illinois	United States	60201
42	American Research, LLC	Jeffersonville	Indiana	United States	47130
43	Gastroenterology of Southern Indiana	New Albany	Indiana	United States	47150
44	Health Science Research Center	Pratt	Kansas	United States	67124
45	WestGlen Gastrointestinal Consultants	Shawnee Mission	Kansas	United States	67214
46	Kansas Medical Clinic	Topeka	Kansas	United States	66606
47	Professional Research Network of Kansas, LLC	Wichita	Kansas	United States	67205
48	Via Christi Clinic, PA	Wichita	Kansas	United States	67208
49	Tri-State Gastroenterology	Crestview Hills	Kentucky	United States	41017
50	WK Physicians Network	Bossier City	Louisiana	United States	71111
51	Avant Research Associates LLC	Crowley	Louisiana	United States	70526
52	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana	United States	70601
53	Tandem Clinical Research	Marrero	Louisiana	United States	70072
54	Clinical Trials of America, Inc.	West Monroe	Louisiana	United States	71291
55	Trialspark - Sood	Bowie	Maryland	United States	20716
56	Capital Diabetes and Endocrine Associates	Camp Springs	Maryland	United States	20746
57	Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
58	Woodholme Gastroenterology Associates, P.A.	Glen Burnie	Maryland	United States	21061
59	Meritus Center for Clinical Research	Hagerstown	Maryland	United States	21742
60	Meridian Clinical Research, LLC	Rockville	Maryland	United States	20854
61	Commonwealth Clinical Studies, PLLC.	Brockton	Massachusetts	United States	02302
62	Clinical Research Institute of Michigan	Chesterfield	Michigan	United States	48047
63	Aa Mrc Llc	Flint	Michigan	United States	48504
64	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
65	Synexus Clinical Research US, Inc	Saint Louis	Missouri	United States	63141
66	Heartland Clinical Research, Inc	Omaha	Nebraska	United States	68134
67	USMA Clinical Research, LLC	Elizabeth	New Jersey	United States	07201
68	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico	United States	87108
69	Synexus Clinical Research US, Inc.	Jamaica	New York	United States	11432
70	Winthrop-University Hospital	Mineola	New York	United States	11501
71	Carolina Digestive Health Associates, PA	Davidson	North Carolina	United States	28036
72	Kinston Medical Specialists, P.A.	Kinston	North Carolina	United States	28501
73	Diabetes and Endocrinology Consultants, PC	Morehead City	North Carolina	United States	28557
74	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
75	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
76	Synexus Clinical Research US, Inc.	Akron	Ohio	United States	44311
77	Diabetes & Endocrinology Associates of Stark County, Inc.	Canton	Ohio	United States	44718
78	Synexus Clinical Research US - Cincinnati	Cincinnati	Ohio	United States	45236
79	Synexus Clinical Research US, Inc	Cincinnati	Ohio	United States	45249
80	The MetroHealth System MHS	Cleveland	Ohio	United States	44109-1998
81	Digestive Disease & Surgery Institute	Cleveland	Ohio	United States	44195
82	The Ohio State University, Wexner Medical Center	Columbus	Ohio	United States	43203
83	Aventiv Research, Inc.	Columbus	Ohio	United States	43213
84	CIC America Clinical Inquest Center Ltd.	Dayton	Ohio	United States	45409
85	Hometown Urgent Care and Research	Dayton	Ohio	United States	45424
86	Centennial Health-Synexus	Oklahoma City	Oklahoma	United States	73111
87	Options Health Research, LLC	Tulsa	Oklahoma	United States	74104
88	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
89	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania	United States	15212
90	Guthrie Clinical Research	Sayre	Pennsylvania	United States	18840
91	Frontier Clinical Research, LLC	Smithfield	Pennsylvania	United States	15478
92	Preferred Primary Care Physicians	Uniontown	Pennsylvania	United States	15401
93	Care Access Research	Warwick	Rhode Island	United States	02886
94	Synexus Clinical Research US, Inc.	Anderson	South Carolina	United States	29621
95	Clinical Trials of South Carolina	Charleston	South Carolina	United States	29406
96	Health Concepts	Rapid City	South Dakota	United States	57702
97	Clinsearch	Chattanooga	Tennessee	United States	37421
98	Gastro One	Germantown	Tennessee	United States	38138
99	East Tennessee Research Institute	Johnson City	Tennessee	United States	37604
100	Texas Clinical Research Institute, LLC	Arlington	Texas	United States	76012
101	ClinRx Research, LLC	Carrollton	Texas	United States	75007
102	Baylor College of Medicine Medical Center	Houston	Texas	United States	77030
103	Biopharma Informatic Inc., Research Center	Houston	Texas	United States	77043
104	Houston Endoscopy and Research Center, Inc.	Houston	Texas	United States	77079
105	Rodriguez Clinical Trials	Houston	Texas	United States	77083
106	Sante Clinical Research	Kerrville	Texas	United States	78028
107	Pinnacle Clinical Research	San Antonio	Texas	United States	78215
108	Synexus Clinical Research US, Inc.	San Antonio	Texas	United States	78229
109	Digestive & Liver Disease Center of San Antonio, PLLC	San Antonio	Texas	United States	78233
110	Dwayne O. Williams MD	Sugar Land	Texas	United States	77479
111	Blue Ridge Medical Research	Lynchburg	Virginia	United States	24502
112	Manassas Clinical Research Centre	Manassas	Virginia	United States	20110
113	VA Medical Center McGuire VAMC	Richmond	Virginia	United States	23249
114	Washington Gastroenterology PLLC	Tacoma	Washington	United States	98405
115	Maffei Centro Medico-Investigacion Clinica Aplicada	C.a.b.a.	Buenos Aires Province	Argentina	C1425AGC
116	Hospital Sirio Libanes	Caba	Buenos Aires Province	Argentina	C1419AHN
117	Centro de Investigaciones Medicas Mar del Plata SRL	Mar del Plata	Buenos Aires Province	Argentina	B7600FYK
118	Instituto Privado de Investigaciones Clínicas de Córdoba	Córdoba	Cordoba	Argentina	X5000AAW
119	Instituto de Investigaciones Clinicas de Rosario	Rosario	Santa Fe	Argentina	2000
120	Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli	Rosario	Santa Fe	Argentina	S200CFK
121	Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias	San Miguel de Tucuman	Tucuman	Argentina	4000
122	CIPREC	Ciudad Autonoma de Buenos Aires		Argentina	1119
123	Centro Universitario de Investigacion en Farmacologia Clinic	Corrientes		Argentina	W3410AVV
124	CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian	Córdoba		Argentina	X5000BNB
125	Ordination	Sankt Stefan	Steiermark	Austria	8511
126	VIVIT Institute, am LKH Feldkirch	Feldkirch	Vorarlberg	Austria	6807
127	Privatklinik Wehrle-Diakonissen	Salzburg		Austria	5020
128	Oö. Gesundheits- und Spitals-AG/LKH Steyr	Steyr		Austria	4400
129	AZ Sint Lucas Brugge	Brugge	Antwerpen	Belgium	2650
130	Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,	Edegem	Antwerp	Belgium	2650
131	UZ Brussel	Jette	Brussel	Belgium	1090
132	Hospital Universitario Walter Cantidio	Fortaleza	Ceara	Brazil	60430-372
133	Centro de Pesquisa Clinica do Brasil	Brasilia	Distrito Federal	Brazil	71625175
134	Hospital Universitario Joao de Barros Barreto	Belem	Para	Brazil	66073-000
135	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul	Brazil	90430-001
136	Instituto Catarinense de Endocrinologia e Diabetes (ICED)	Joinville	Santa Catarina	Brazil	89201-260
137	Scentryphar Pesquisa Clinica Ltda	Campinas	Sao Paulo	Brazil	13020-431
138	Instituto de Pesquisa Clinica em Campinas	Campinas	Sao Paulo	Brazil	13060-080
139	CPQuali Pesquisa Clinica Ltda	Santa Cecília	Sao Paulo	Brazil	01228-000
140	Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology	Fortaleza		Brazil	60160-230
141	Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda	SÃo Paulo		Brazil	01223-001
142	University of Calgary	Calgary	Alberta	Canada	T2N 2T9
143	Alberta Diabetes Institute	Edmonton	Alberta	Canada	T6G 2E1
144	Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia	Canada	V5Z1M9
145	Eastern Health	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
146	South Shore Medical Arts	Bridgewater	Nova Scotia	Canada	B4V 2V6
147	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 7W9
148	Sunnybrook Health Science Centre	Toronto	Ontario	Canada	M4N 3M5
149	Toronto Western Hospital, University Health Network	Toronto	Ontario	Canada	M5T 2S8
150	Toronto Liver Centre	Toronto	Ontario	Canada	M6H 3M1
151	Toronto Digestive Disease Associates	Vaughan	Ontario	Canada	L4L 4YZ
152	CISSS de la Monteregie-Centre	Greenfield Park	Quebec	Canada	J4V 2H1
153	Recherche GCP Research	Montreal	Quebec	Canada	H1M 1B1
154	Centre Hospitalier de l'Universite de Montreal - CHUM	Montreal	Quebec	Canada	H2X 0A9
155	Central Alberta Research Centre	Red Deer		Canada	T4N 6V7
156	Centro Cardiovascular Colombiano Clínica Santa María	Medellin	Antioquia	Colombia	050034
157	Rodrigo Botero S.A.S.	Medellin	Antioquia	Colombia	50030
158	Centro Cardiovascular y de Diabetes	Barranquilla	Atlantico	Colombia	080020
159	Fundacion Bios	Barranquilla	Atlantico	Colombia	080020
160	Asociación Colombiana de Diabetes	Bogotá	Cundinamarca	Colombia	111311
161	Healthy Medical Center	Zipaquira	Cundinamarca	Colombia	250252
162	Medplus Mp	Bogota	Distrito Capital De Bogotá	Colombia	110221
163	Endocare Ltda.	Bogota	Distrito Capital De Bogotá	Colombia	111111
164	Fundacion Centro de Investigaciones Clinicas CARDIOMET	Pereira	Risaralda	Colombia	660002
165	IPS Centro Medico Julian Coronel S.A	Cali	Valle Del Cauca	Colombia	760035
166	Centro Medico Imbanaco de Cali S.A.	Cali	Valle Del Cauca	Colombia	760042
167	Gastroenheden, Hvidovre hospital	Hvidovre	Copenhagen	Denmark	2605
168	Endocrinology, Aalborg University Hospital	Aalborg		Denmark	DK-9000
169	Center for Clinical Metabolic Research	Hellerup		Denmark	2900
170	Klinische Forschung Karlsruhe GmbH	Karlsruhe	Baden-SWürttemberg	Germany	76199
171	Studienzentrum Schwittay	Böhlen	Saxony	Germany	4564
172	Klinische Forschung Dresden GmbH	Dresden	Saxony	Germany	1309
173	Clinical Research Unit	Giessen		Germany	32392
174	Clinical Research Hamburg	Hamburg		Germany	22143
175	Israelitisches Krankenhaus	Hamburg		Germany	22297
176	KRH Klinikum Siloah	Hannover		Germany	30459
177	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger	Heves	Hungary	H-3300
178	BKS Research Kft Synexus AS	Hatvan	Heves	Hungary	3000
179	Hetenyi Geza Hospital	Szolnok	Jász-Nagykun-Szolnok	Hungary	H-5004
180	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Zala	Hungary	H-8900
181	Synexus Budapest DRS	Budapest		Hungary	1036
182	Strázsahegy Gyógyszertár Medicina	Budapest		Hungary	H1171
183	SYNEXUS Magyarorszag Kft Debrecen A.S.	Debrecen		Hungary	4025
184	Synexus Magyarország kft. Gyula DRS	Gyula		Hungary	5700
185	Szegedi Tudomanyegyetem	Szeged		Hungary	H-6720
186	Synexus Magyarorszag Kft	Zalaegerszeg		Hungary	8900
187	Polana-D	Daugavpils		Latvia	5401
188	Kraslava Hospital	Kraslava		Latvia	5601
189	Pauls Stradins Clinical University Hospital, Endokrinologijas nodala	Riga		Latvia	1002
190	Digestive Diseases Centre GASTRO	Riga		Latvia	1006
191	Medical and Nutritional Trials	Cuauhtemoc	Cdmx	Mexico	06700
192	Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology	Mexico	Distrito Federal	Mexico	11650
193	Centro de Atención e Investigación en Factores de Riesgo Car	Mexico	Distrito Federal	Mexico	14000
194	Clinicos Asociados BOCM SC	Portales	Distrito Federal	Mexico	03300
195	Unidad de Investigacion Clinica Cardiometabolica de Occidente	Guadalajara	Jalisco	Mexico	44150
196	Consultorio Medico	Guadalajara	Jalisco	Mexico	C.P. 44210
197	Unidad de Investigación Clínica en Medicina S.C.	Guadalajara	Jalisco	Mexico	C.P. 44670
198	Centro de Desarrollo Biomedico S.C.P.	Mérida	Yucatan	Mexico	97070
199	Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV	Aguascalientes		Mexico	20230
200	Hospital Cardiologica Aguascalientes	Aguascalientes		Mexico	20230
201	Dioderm Instituto de Investigacion	Durango		Mexico	34060
202	Sociedad de Metabolismo y Corazon, S.C.	Veracruz		Mexico	C.P. 91900
203	Saint-Petersburg City Pokrovskaya Hospital	St-Petersburg	Leningrad Region	Russian Federation	199106
204	Scientific Institute of Clinical and Experimental Lymphology	Novosibirsk	Novosibirsk Oblast	Russian Federation	630117
205	GUZ Saratov City Clinical Hospital 9	Saratov	Saratov Region	Russian Federation	410030
206	Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko	Nizhny Novgorod	Volga	Russian Federation	603126
207	Kazan State Medical University	Kazan		Russian Federation	420012
208	FSBI National medical endocrinology research centre	Moscow		Russian Federation	117036
209	Moscow Regional Research Clinical Institute named by MF Vladimirski	Moscow		Russian Federation	129110
210	Rostov on Don	Rostov on Don		Russian Federation	344019
211	Rostov State Medical University	Rostov-on-Don		Russian Federation	344022
212	North-Western State Medical University named after I. I. Mechnikov	Saint-Petersburg		Russian Federation	191015
213	Saratov City Clinical Hospital 12	Saratov		Russian Federation	410039
214	FARMOVS	Bloemfontein	Free State	South Africa	9301
215	Wits Clinical Research	Johannesburg	Gauteng	South Africa	2193
216	Synexus Stanza Clinical Research Centre	Pretoria	Gauteng	South Africa	0122
217	Watermeyer Clinical Research Site	Silverton	Gauteng	South Africa	184
218	Synexus Helderberg Clinical Research Centre	Cape Town	Western Cape	South Africa	7130
219	TREAD Research	Cape Town		South Africa	7500
220	MAC Clinical Research Manchester	Manchester	Greater Manchester	United Kingdom	M13 9NQ
221	Synexus Lancashire Dedicated Research Centre	Chorley	Lancashire	United Kingdom	PR7 7NA
222	Royal Oldham Hospital	Oldham	Lancashire	United Kingdom	OL1 2JH
223	MAC Research, Exchange House	Cannock	Staffordshire	United Kingdom	WS11 0BH
224	University Hospitals of North Midlands	Stoke on Trent	Staffordshire	United Kingdom	ST6 8DG
225	Royal Wolverhampton NHS Trust	Wolverhampton	West Midlands	United Kingdom	WV10 0QP
226	MAC Clinical Research, Monarch House	Leeds	West Yorkshire	United Kingdom	LS10 1DU
227	MAC Research	Barnsley		United Kingdom	S75 3DL
228	MAC Clinical Research	Blackpool		United Kingdom	FY2 0JH
229	Synexus Wales Clinical Research Centre	Cardiff		United Kingdom	CF15 9SS
230	Mid Essex Hospital Services NHS Trust Broomfield Hospital	Chelmsford		United Kingdom	CM1 7ET
231	Western General Hospital	Edinburgh		United Kingdom	EH4 2XU
232	Synexus Merseyside Dedicated Research Centre	Liverpool		United Kingdom	L22 0LG
233	MAC Clinical Research	Liverpool		United Kingdom	L34 1BH
234	Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital	London		United Kingdom	E1 2AJ
235	MAC Clinical Research, GAC House	Manchester		United Kingdom	M13 9NQ
236	Synexus Manchester Clinical Research Centre	Manchester		United Kingdom	M15 6SX
237	Royal Victoria Infirmary: Clinical Research Facility	Newcastle upon Tyne		United Kingdom	NE7 7DN
238	Biomedical Research Centre	Nottingham		United Kingdom	NG7 2UH
239	Synexus Hexham Dedicated Research Centre	Stockton-on-Tees		United Kingdom	TS19 8PE
240	Synexus North Tees Clinical Research Centre	Stockton-on-Tees		United Kingdom	TS19 8PE

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Wieslaw (Wes) Bochenek, MD, PhD, Allergan

Study Documents (Full-Text)

• Study Protocol - Mar 5, 2019
• Statistical Analysis Plan - Nov 17, 2020

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03426345
• Other Study ID Numbers: RLM-MD-02; 2017-002177-20
• First Posted: Feb 8, 2018
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroparesis

Study Results

Participant Flow

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
Period Title: Overall Study
STARTED	155	156
Safety Population	152	155
COMPLETED	137	139
NOT COMPLETED	18	17

Baseline Characteristics

Arm/Group Title	Placebo	Relamorelin 10 μg	Total
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.	Total of all reporting groups
Overall Participants	155	156	311
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.1 (12.13)	55.8 (12.07)	55.0 (12.11)
Sex: Female, Male (Count of Participants)
Female	112 72.3%	114 73.1%	226 72.7%
Male	43 27.7%	42 26.9%	85 27.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	54 34.8%	51 32.7%	105 33.8%
Not Hispanic or Latino	101 65.2%	105 67.3%	206 66.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 2.6%	7 4.5%	11 3.5%
Asian	1 0.6%	2 1.3%	3 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	25 16.1%	17 10.9%	42 13.5%
White	123 79.4%	127 81.4%	250 80.4%
More than one race	2 1.3%	3 1.9%	5 1.6%
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)
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.
Time Frame	Baseline (Day-14 to Day-1) to Week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Baseline	23.4 (5.40)	24.9 (6.15)
Change from Baseline to Week 12	-9.3 (10.21)	-10.2 (9.24)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Number [percentage of participants]	19.1 12.3%	18.7 12%

3. Secondary Outcome

Title	Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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.
Time Frame	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Number [percentage of participants]	32.9 21.2%	38.1 24.4%

4. Secondary Outcome

Title	Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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.
Time Frame	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Number [percentage of participants]	27.0 17.4%	36.1 23.1%

5. Secondary Outcome

Title	Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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.
Time Frame	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Number [percentage of participants]	27.0 17.4%	31.6 20.3%

6. Secondary Outcome

Title	Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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).
Time Frame	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Number [percentage of participants]	23.7 15.3%	27.7 17.8%

7. 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	Up to approximately 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Count of Participants [Participants]	75 48.4%	86 55.1%

8. Secondary Outcome

Title	Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Description	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.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN)	0 0%	1 0.6%
Hematocrit (RATIO): >1.1×ULN	1 0.6%	0 0%
Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)	4 2.6%	4 2.6%
Hemoglobin [grams (g)/L]: <0.9×LLN	2 1.3%	5 3.2%
Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN	1 0.6%	3 1.9%
Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN	1 0.6%	1 0.6%
Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN	0 0%	1 0.6%
Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN	2 1.3%	2 1.3%
Red Blood Cell Count (10^12/L): <0.9×LLN	1 0.6%	1 0.6%
Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN	1 0.6%	0 0%
Albumin (g/L): <0.9×LLN	0 0%	1 0.6%
Alkaline Phosphatase (U/L): >=3×ULN	1 0.6%	0 0%
Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN	1 0.6%	2 1.3%
Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN	0 0%	1 0.6%
Bicarbonate (HCO3) (mmol/L): <0.9×LLN	1 0.6%	0 0%
Blood Urea Nitrogen (mmol/L): >1.2×ULN	15 9.7%	3 1.9%
Chloride (mmol/L): <0.9×LLN	2 1.3%	0 0%
Cholesterol, Total, Fasting (mmol/L): >1.6×ULN	2 1.3%	1 0.6%
Creatinine [micromoles(μmol)/L]: >1.3×ULN	8 5.2%	7 4.5%
Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN	11 7.1%	21 13.5%
Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN	6 3.9%	5 3.2%
Glycohemoglobin A1C: Increase of >=0.5%	80 51.6%	111 71.2%
Glycohemoglobin A1C: Increase of >=1%	80 51.6%	111 71.2%
Phosphorus (mmol/L): >1.1×ULN	5 3.2%	5 3.2%
Phosphorus (mmol/L): <0.9×LLN	1 0.6%	1 0.6%
Potassium (mmol/L): <0.9×LLN	1 0.6%	0 0%
Sodium (mmol/L): <0.9×LLN	1 0.6%	0 0%
Triglycerides, Fasting (mmol/L): >=3×ULN	3 1.9%	5 3.2%
Uric Acid (Urate) (μmol/L): >1.1×ULN	18 11.6%	13 8.3%
Uric Acid (Urate) (μmol/L): <0.9×LLN	3 1.9%	0 0%

9. 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 abnormal results were clinically significant.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Count of Participants [Participants]	0 0%	0 0%

10. 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 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	152	155
Count of Participants [Participants]	1 0.6%	2 1.3%

11. Secondary Outcome

Title	Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Time Frame	Baseline (Day 1) up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	146	151
Count of Participants [Participants]	80 51.6%	111 71.2%

12. Secondary Outcome

Title	Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
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. 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.
Time Frame	Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received ≥1 administration of double-blind study treatment (N=155 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.

Arm/Group Title	Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants	155
Negative	127 81.9%
Positive	18 11.6%
Negative	12 7.7%
Positive	0 0%
Negative	115 74.2%
Positive	18 11.6%
Negative	13 8.4%
Positive	0 0%
Negative	104 67.1%
Positive	17 11%
Negative	12 7.7%
Positive	0 0%
Negative	87 56.1%
Positive	17 11%
Negative	11 7.1%
Positive	1 0.6%
Negative	6 3.9%
Positive	1 0.6%
Negative	1 0.6%
Positive	0 0%
Negative	6 3.9%
Positive	0 0%
Negative
Positive

Adverse Events

Time Frame	Up to approximately 16 weeks
Adverse Event Reporting Description	All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Arm/Group Title	Placebo		Relamorelin 10 μg
Arm/Group Description	Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.		Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
All Cause Mortality
	Placebo		Relamorelin 10 μg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/155 (0%)		0/156 (0%)
Serious Adverse Events
	Placebo		Relamorelin 10 μg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/152 (3.9%)		8/155 (5.2%)
Cardiac disorders
Cardiac failure congestive	1/152 (0.7%)		1/155 (0.6%)
Gastrointestinal disorders
Abdominal pain	0/152 (0%)		1/155 (0.6%)
Diarrhoea	0/152 (0%)		1/155 (0.6%)
Nausea	0/152 (0%)		1/155 (0.6%)
Small intestinal obstruction	0/152 (0%)		1/155 (0.6%)
Vomiting	0/152 (0%)		1/155 (0.6%)
Infections and infestations
COVID-19	0/152 (0%)		1/155 (0.6%)
Pneumonia	0/152 (0%)		1/155 (0.6%)
Urinary tract infection	0/152 (0%)		1/155 (0.6%)
Influenza	1/152 (0.7%)		0/155 (0%)
Sepsis	1/152 (0.7%)		0/155 (0%)
Upper respiratory tract infection	1/152 (0.7%)		0/155 (0%)
Metabolism and nutrition disorders
Dehydration	1/152 (0.7%)		1/155 (0.6%)
Diabetic ketoacidosis	1/152 (0.7%)		1/155 (0.6%)
Malnutrition	1/152 (0.7%)		0/155 (0%)
Musculoskeletal and connective tissue disorders
Muscular weakness	1/152 (0.7%)		0/155 (0%)
Nervous system disorders
Headache	1/152 (0.7%)		0/155 (0%)
Renal and urinary disorders
Acute kidney injury	0/152 (0%)		1/155 (0.6%)
Renal failure	1/152 (0.7%)		0/155 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage	0/109 (0%)		1/113 (0.9%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/152 (0.7%)		0/155 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Relamorelin 10 μg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/152 (9.2%)		13/155 (8.4%)
Gastrointestinal disorders
Diarrhoea	9/152 (5.9%)		5/155 (3.2%)
Infections and infestations
Urinary tract infection	5/152 (3.3%)		9/155 (5.8%)

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.