Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
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 |
---|---|---|
|
Phase 3 |
Study Design
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
- 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.
- 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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [Baseline (Day 1) up to 12 weeks]
- 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
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)
More Information
Publications
None provided.- RLM-MD-02
- 2017-002177-20
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
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
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)
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
Title | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) |
---|---|
Description | |
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%
|
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
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.
Results Point of Contact
Name/Title | Therapeutic Area, Head |
---|---|
Organization | Allergan |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- RLM-MD-02
- 2017-002177-20