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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03426345
• Other study ID #: RLM-MD-02
• Secondary ID: 2017-002177-20
• Status: Terminated
• Phase: Phase 3
• Start date: February 16, 2018
• Est. completion date: July 16, 2020

Study information

• Verified date: July 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 311
• Est. completion date: July 16, 2020
• Est. primary completion date: July 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastroparesis

Intervention

Drug:
• Placebo
Placebo injected subcutaneously twice daily.
• Relamorelin
Relamorelin 10 µg injected twice daily for 12 weeks.

Locations

Country	Name	City	State
Argentina	Maffei Centro Medico-Investigacion Clinica Aplicada	C.a.b.a.	Buenos Aires Province
Argentina	Hospital Sirio Libanes	Caba	Buenos Aires Province
Argentina	CIPREC	Ciudad Autonoma de Buenos Aires
Argentina	CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian	Córdoba
Argentina	Instituto Privado de Investigaciones Clínicas de Córdoba	Córdoba	Cordoba
Argentina	Centro Universitario de Investigacion en Farmacologia Clinic	Corrientes
Argentina	Centro de Investigaciones Medicas Mar del Plata SRL	Mar del Plata	Buenos Aires Province
Argentina	Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli	Rosario	Santa Fe
Argentina	Instituto de Investigaciones Clinicas de Rosario	Rosario	Santa Fe
Argentina	Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias	San Miguel de Tucuman	Tucuman
Austria	VIVIT Institute, am LKH Feldkirch	Feldkirch	Vorarlberg
Austria	Privatklinik Wehrle-Diakonissen	Salzburg
Austria	Ordination	Sankt Stefan	Steiermark
Austria	Oö. Gesundheits- und Spitals-AG/LKH Steyr	Steyr
Belgium	AZ Sint Lucas Brugge	Brugge	Antwerpen
Belgium	Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,	Edegem	Antwerp
Belgium	UZ Brussel	Jette	Brussel
Brazil	Hospital Universitario Joao de Barros Barreto	Belem	Para
Brazil	Centro de Pesquisa Clinica do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa Clinica em Campinas	Campinas	Sao Paulo
Brazil	Scentryphar Pesquisa Clinica Ltda	Campinas	Sao Paulo
Brazil	Hospital Universitario Walter Cantidio	Fortaleza	Ceara
Brazil	Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology	Fortaleza
Brazil	Instituto Catarinense de Endocrinologia e Diabetes (ICED)	Joinville	Santa Catarina
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	CPQuali Pesquisa Clinica Ltda	Santa Cecília	Sao Paulo
Brazil	Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda	SÃo Paulo
Canada	South Shore Medical Arts	Bridgewater	Nova Scotia
Canada	University of Calgary	Calgary	Alberta
Canada	Alberta Diabetes Institute	Edmonton	Alberta
Canada	CISSS de la Monteregie-Centre	Greenfield Park	Quebec
Canada	Centre Hospitalier de l'Universite de Montreal - CHUM	Montreal	Quebec
Canada	Recherche GCP Research	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Central Alberta Research Centre	Red Deer
Canada	Eastern Health	St. John's	Newfoundland and Labrador
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	Toronto Liver Centre	Toronto	Ontario
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario
Canada	Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates	Vaughan	Ontario
Colombia	Centro Cardiovascular y de Diabetes	Barranquilla	Atlantico
Colombia	Fundacion Bios	Barranquilla	Atlantico
Colombia	Endocare Ltda.	Bogota	Distrito Capital De Bogotá
Colombia	Medplus Mp	Bogota	Distrito Capital De Bogotá
Colombia	Asociación Colombiana de Diabetes	Bogotá	Cundinamarca
Colombia	Centro Medico Imbanaco de Cali S.A.	Cali	Valle Del Cauca
Colombia	IPS Centro Medico Julian Coronel S.A	Cali	Valle Del Cauca
Colombia	Centro Cardiovascular Colombiano Clínica Santa María	Medellin	Antioquia
Colombia	Rodrigo Botero S.A.S.	Medellin	Antioquia
Colombia	Fundacion Centro de Investigaciones Clinicas CARDIOMET	Pereira	Risaralda
Colombia	Healthy Medical Center	Zipaquira	Cundinamarca
Denmark	Endocrinology, Aalborg University Hospital	Aalborg
Denmark	Center for Clinical Metabolic Research	Hellerup
Denmark	Gastroenheden, Hvidovre hospital	Hvidovre	Copenhagen
Germany	Studienzentrum Schwittay	Böhlen	Saxony
Germany	Klinische Forschung Dresden GmbH	Dresden	Saxony
Germany	Clinical Research Unit	Giessen
Germany	Clinical Research Hamburg	Hamburg
Germany	Israelitisches Krankenhaus	Hamburg
Germany	KRH Klinikum Siloah	Hannover
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe	Baden-SWürttemberg
Hungary	Strázsahegy Gyógyszertár Medicina	Budapest
Hungary	Synexus Budapest DRS	Budapest
Hungary	SYNEXUS Magyarorszag Kft Debrecen A.S.	Debrecen
Hungary	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger	Heves
Hungary	Synexus Magyarország kft. Gyula DRS	Gyula
Hungary	BKS Research Kft Synexus AS	Hatvan	Heves
Hungary	Szegedi Tudomanyegyetem	Szeged
Hungary	Hetenyi Geza Hospital	Szolnok	Jász-Nagykun-Szolnok
Hungary	Synexus Magyarorszag Kft	Zalaegerszeg
Hungary	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Zala
Latvia	Polana-D	Daugavpils
Latvia	Kraslava Hospital	Kraslava
Latvia	Digestive Diseases Centre GASTRO	Riga
Latvia	Pauls Stradins Clinical University Hospital, Endokrinologijas nodala	Riga
Mexico	Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV	Aguascalientes
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Medical and Nutritional Trials	Cuauhtemoc	Cdmx
Mexico	Dioderm Instituto de Investigacion	Durango
Mexico	Consultorio Medico	Guadalajara	Jalisco
Mexico	Unidad de Investigacion Clinica Cardiometabolica de Occidente	Guadalajara	Jalisco
Mexico	Unidad de Investigación Clínica en Medicina S.C.	Guadalajara	Jalisco
Mexico	Centro de Desarrollo Biomedico S.C.P.	Mérida	Yucatan
Mexico	Centro de Atención e Investigación en Factores de Riesgo Car	Mexico	Distrito Federal
Mexico	Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology	Mexico	Distrito Federal
Mexico	Clinicos Asociados BOCM SC	Portales	Distrito Federal
Mexico	Sociedad de Metabolismo y Corazon, S.C.	Veracruz
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	FSBI National medical endocrinology research centre	Moscow
Russian Federation	Moscow Regional Research Clinical Institute named by MF Vladimirski	Moscow
Russian Federation	Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko	Nizhny Novgorod	Volga
Russian Federation	Scientific Institute of Clinical and Experimental Lymphology	Novosibirsk	Novosibirsk Oblast
Russian Federation	Rostov on Don	Rostov on Don
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	North-Western State Medical University named after I. I. Mechnikov	Saint-Petersburg
Russian Federation	GUZ Saratov City Clinical Hospital 9	Saratov	Saratov Region
Russian Federation	Saratov City Clinical Hospital 12	Saratov
Russian Federation	Saint-Petersburg City Pokrovskaya Hospital	St-Petersburg	Leningrad Region
South Africa	FARMOVS	Bloemfontein	Free State
South Africa	Synexus Helderberg Clinical Research Centre	Cape Town	Western Cape
South Africa	TREAD Research	Cape Town
South Africa	Wits Clinical Research	Johannesburg	Gauteng
South Africa	Synexus Stanza Clinical Research Centre	Pretoria	Gauteng
South Africa	Watermeyer Clinical Research Site	Silverton	Gauteng
United Kingdom	MAC Research	Barnsley
United Kingdom	MAC Clinical Research	Blackpool
United Kingdom	MAC Research, Exchange House	Cannock	Staffordshire
United Kingdom	Synexus Wales Clinical Research Centre	Cardiff
United Kingdom	Mid Essex Hospital Services NHS Trust Broomfield Hospital	Chelmsford
United Kingdom	Synexus Lancashire Dedicated Research Centre	Chorley	Lancashire
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	MAC Clinical Research, Monarch House	Leeds	West Yorkshire
United Kingdom	MAC Clinical Research	Liverpool
United Kingdom	Synexus Merseyside Dedicated Research Centre	Liverpool
United Kingdom	Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital	London
United Kingdom	MAC Clinical Research Manchester	Manchester	Greater Manchester
United Kingdom	MAC Clinical Research, GAC House	Manchester
United Kingdom	Synexus Manchester Clinical Research Centre	Manchester
United Kingdom	Royal Victoria Infirmary: Clinical Research Facility	Newcastle upon Tyne
United Kingdom	Biomedical Research Centre	Nottingham
United Kingdom	Royal Oldham Hospital	Oldham	Lancashire
United Kingdom	Synexus Hexham Dedicated Research Centre	Stockton-on-Tees
United Kingdom	Synexus North Tees Clinical Research Centre	Stockton-on-Tees
United Kingdom	University Hospitals of North Midlands	Stoke on Trent	Staffordshire
United Kingdom	Royal Wolverhampton NHS Trust	Wolverhampton	West Midlands
United States	Synexus Clinical Research US, Inc.	Akron	Ohio
United States	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Visionary Investigators Network	Aventura	Florida
United States	Synexus Clinical Research US - Simon Williamson Clinic	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	WK Physicians Network	Bossier City	Louisiana
United States	Trialspark - Sood	Bowie	Maryland
United States	Gastroenterology Associates of Fairfield County, P.C.	Bridgeport	Connecticut
United States	Commonwealth Clinical Studies, PLLC.	Brockton	Massachusetts
United States	Gwinnett Research Institute, LLC	Buford	Georgia
United States	Capital Diabetes and Endocrine Associates	Camp Springs	Maryland
United States	Diabetes & Endocrinology Associates of Stark County, Inc.	Canton	Ohio
United States	ClinRx Research, LLC	Carrollton	Texas
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Clinsearch	Chattanooga	Tennessee
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Synexus Clinical Research US, Inc.	Chicago	Illinois
United States	GW Research Inc.	Chula Vista	California
United States	Synexus Clinical Research US - Cincinnati	Cincinnati	Ohio
United States	Synexus Clinical Research US, Inc	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Digestive Disease & Surgery Institute	Cleveland	Ohio
United States	The MetroHealth System MHS	Cleveland	Ohio
United States	Synexus Clinical Research US, Inc. - Colorado Springs Family Practice	Colorado Springs	Colorado
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	The Ohio State University, Wexner Medical Center	Columbus	Ohio
United States	ALL Medical Research LLC	Cooper City	Florida
United States	Tri-State Gastroenterology	Crestview Hills	Kentucky
United States	Avant Research Associates LLC	Crowley	Louisiana
United States	Carolina Digestive Health Associates, PA	Davidson	North Carolina
United States	CIC America Clinical Inquest Center Ltd.	Dayton	Ohio
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	iResearch Atlanta LLC	Decatur	Georgia
United States	USMA Clinical Research, LLC	Elizabeth	New Jersey
United States	Diagnamics Inc.	Encinitas	California
United States	North Shore University Health System	Evanston	Illinois
United States	Aa Mrc Llc	Flint	Michigan
United States	G & L Research, LLC	Foley	Alabama
United States	Fresno Clinical Research Center	Fresno	California
United States	Gastro One	Germantown	Tennessee
United States	Woodholme Gastroenterology Associates, P.A.	Glen Burnie	Maryland
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Palmetto Research, LLC	Hialeah	Florida
United States	Vida Clinical Trials	Homestead	Florida
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	Biopharma Informatic Inc., Research Center	Houston	Texas
United States	Houston Endoscopy and Research Center, Inc.	Houston	Texas
United States	Rodriguez Clinical Trials	Houston	Texas
United States	Rocky Mountain Diabetes and Osteoporosis Center, PA	Idaho Falls	Idaho
United States	Synexus Clinical Research US, Inc.	Jamaica	New York
United States	American Research, LLC	Jeffersonville	Indiana
United States	East Tennessee Research Institute	Johnson City	Tennessee
United States	Sante Clinical Research	Kerrville	Texas
United States	Kinston Medical Specialists, P.A.	Kinston	North Carolina
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Torrance Clinical Research Institute, Inc.	Lomita	California
United States	Tibor Rubin VA Medical Center	Long Beach	California
United States	Angel City Research Inc.	Los Angeles	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Manassas Clinical Research Centre	Manassas	Virginia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Sanchez Clinical Research, Inc.	Miami	Florida
United States	Winthrop-University Hospital	Mineola	New York
United States	Facey Medical Foundation	Mission Hills	California
United States	Alabama Medical Group, PC	Mobile	Alabama
United States	Diabetes and Endocrinology Consultants, PC	Morehead City	North Carolina
United States	United Medical Doctors	Murrieta	California
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Gastroenterology of Southern Indiana	New Albany	Indiana
United States	Centennial Health-Synexus	Oklahoma City	Oklahoma
United States	Heartland Clinical Research, Inc	Omaha	Nebraska
United States	Stanford Hospital, Digestive Health Clinic	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Synexus	Pinellas Park	Florida
United States	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania
United States	TriWest Research Associates	Poway	California
United States	Health Science Research Center	Pratt	Kansas
United States	Health Concepts	Rapid City	South Dakota
United States	VA Medical Center McGuire VAMC	Richmond	Virginia
United States	Meridian Clinical Research, LLC	Rockville	Maryland
United States	Synexus Clinical Research US, Inc	Saint Louis	Missouri
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Digestive & Liver Disease Center of San Antonio, PLLC	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Synexus Clinical Research US, Inc.	San Antonio	Texas
United States	Optimal Research California	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Guthrie Clinical Research	Sayre	Pennsylvania
United States	Unity Health - Searcy Medical Center	Searcy	Arkansas
United States	WestGlen Gastrointestinal Consultants	Shawnee Mission	Kansas
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Dwayne O. Williams MD	Sugar Land	Texas
United States	Clinical Research Consultants of Atlanta	Suwanee	Georgia
United States	Washington Gastroenterology PLLC	Tacoma	Washington
United States	Kansas Medical Clinic	Topeka	Kansas
United States	Synexus Clinical Research US, Inc.	Tucson	Arizona
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Care Access Research	Warwick	Rhode Island
United States	Clinical Trials of America, Inc.	West Monroe	Louisiana
United States	Cleveland Clinic Florida - Weston	Weston	Florida
United States	New Hope Research Development	Whittier	California
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Via Christi Clinic, PA	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Denmark,  Germany,  Hungary,  Latvia,  Mexico,  Russian Federation,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)	Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0= no or not at all uncomfortable to 10= worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period.	Baseline (Day-14 to Day-1) to Week 12
Primary	Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.	Week 6 to Week 12
Secondary	Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no nausea to 10= worst possible nausea.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no abdominal pain to 10= the worst possible abdominal pain and was recorded in an e-diary.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no bloating and 10= the worst possible bloating and was recorded in the e-diary.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no feeling of fullness until finishing a meal (best) to 10= feeling full after only a few bites (worst).	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.	Up to approximately 16 weeks
Secondary	Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results	Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.	Up to 12 weeks
Secondary	Number of Participants With Clinically Meaningful Trends for Vital Signs	Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.	Up to 12 weeks
Secondary	Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results	A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.	Up to 12 weeks
Secondary	Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)		Baseline (Day 1) up to 12 weeks
Secondary	Number of Participants With Anti-relamorelin Antibody Testing Results by Visit	A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.	Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)