A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
ACHIEVE-4
A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
4 other identifiers
interventional
2,749
16 countries
358
Brief Summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Apr 2023
Longer than P75 for phase_3 type-2-diabetes
358 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2026
CompletedApril 17, 2026
April 1, 2026
3 years
March 27, 2023
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Time to First Occurrence of Any MACE-4 (Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular \[CV\] Death)
Baseline to End of the Study (Approximate Maximum 104 Weeks)
Secondary Outcomes (9)
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
Baseline to End of the Study (Approximately 104 Weeks)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 52
Change from Baseline in Fasting Serum Glucose
Baseline, Week 52
Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile
Baseline, Week 52
Percentage of Participants with HbA1c Target Values Less Than (<)7.0% (53 mmol/mol)
Week 52
- +4 more secondary outcomes
Study Arms (2)
Orforglipron
EXPERIMENTALParticipants will receive escalated doses of orforglipron orally.
Insulin Glargine
ACTIVE COMPARATORParticipants will receive insulin glargine subcutaneously (SC). Doses will be individualized and titrated according to a treat-to-target algorithm.
Interventions
Eligibility Criteria
You may qualify if:
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
- Have HbA1c at screening
- ≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
- ≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
- Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
- Have increased risk for cardiovascular (CV) events due to:
- Coronary heart disease
- Peripheral arterial disease, presumed to be of atherosclerotic origin
- Cerebrovascular disease, presumed to be of atherosclerotic origin
- Chronic kidney disease (CKD)
- Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
- Are of stable weight (± 5%) for at least 90 days prior to screening
- Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
You may not qualify if:
- Have type 1 diabetes mellitus
- Have had chronic or acute pancreatitis any time prior to screening
- Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
- Have a known clinically significant gastric emptying abnormality
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
- Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
- Have an eGFR \<15 mL/min/1.73 m2 as determined at screening
- Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
- Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (358)
Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526, United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608, United States
Cahaba Research - Pelham
Pelham, Alabama, 35124, United States
Syed Research Consultants Llc
Sheffield, Alabama, 35660, United States
The Institute for Liver Health
Chandler, Arizona, 85224, United States
Aventiv Research
Mesa, Arizona, 85206, United States
Arizona Liver Health - Peoria
Peoria, Arizona, 85381, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
Absolute Clinical Research
Phoenix, Arizona, 85051, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, 85375, United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281, United States
Orange Grove Family Practice
Tucson, Arizona, 85741, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303, United States
Valley Clinical Trials, Inc.
Covina, California, 91723, United States
Neighborhood Healthcare Institute of Health
Escondido, California, 92025, United States
Valley Research
Fresno, California, 93720, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Pacific Clinical Studies
Los Alamitos, California, 90720, United States
Velocity Clinical Research, Los Angeles
Los Angeles, California, 90017, United States
Infinity Clinical Research - Norco
Norco, California, 92860, United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730, United States
LCGK Research
San Carlos, California, 94070, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583, United States
Velocity Clinical Research, Coastal Heart Medical Group
Santa Ana, California, 92704, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Millennium Clinical Trials
Westlake Village, California, 91361, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Legacy Clinical Trials
Colorado Springs, Colorado, 80909, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517, United States
Orlando Heart & Vascular Institute
Altamonte Springs, Florida, 32714, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, 33912, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Nature Coast Clinical Research - Inverness
Inverness, Florida, 34452, United States
Northeast Research Institute - Downtown Office
Jacksonville, Florida, 32204, United States
Clinical Research of Central Florida
Lakeland, Florida, 33805, United States
Clinical Site Partners Leesburg
Leesburg, Florida, 34748, United States
L&C Professional Medical Research Institute
Miami, Florida, 33144, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Adult Medicine of Lake County
Mt. Dora, Florida, 32757, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
West Orange Endocrinology
Ocoee, Florida, 34761, United States
Better Life Clinical Research
Tampa, Florida, 33607, United States
Precision Research Center
Tampa, Florida, 33614, United States
Care Access - Tampa
Tampa, Florida, 33625, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Encore Medical Research - Weston
Weston, Florida, 33331, United States
Conquest Research
Winter Park, Florida, 32789, United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046, United States
The Jones Center Clinical Research
Macon, Georgia, 31210, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Saltzer Health
Nampa, Idaho, 83686, United States
Elite Clinical Trials
Rexburg, Idaho, 83440, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Midwest CRC
Crystal Lake, Illinois, 60012, United States
AMR Clinical
Oak Brook, Illinois, 60523, United States
NorthShore University Health System
Skokie, Illinois, 60077, United States
American Health Network of Indiana, LLC - Avon
Avon, Indiana, 46123, United States
Investigators Research Group
Brownsburg, Indiana, 46112, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
American Health Network of Indiana, LLC - Franklin
Franklin, Indiana, 46131, United States
American Health Network of Indiana, LLC - Greenfield
Greenfield, Indiana, 46140, United States
American Health Network of Indiana, LLC - Muncie
Muncie, Indiana, 47304, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Cotton O'Neil Mulvane
Topeka, Kansas, 66606, United States
Qualmedica Research
Bowling Green, Kentucky, 42101, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Louisiana Heart Center - Convington
Covington, Louisiana, 70433, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
Revival Research Institute
Dearborn, Michigan, 48126, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
SKY Clinical Research Network Group - Hall
Fayette, Mississippi, 39069, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Diabetes and Endocrinology Specialists
Chesterfield, Missouri, 63017, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128, United States
Palm Research Center Sunset
Las Vegas, Nevada, 89148, United States
Northern Nevada Endocrinology
Reno, Nevada, 89511, United States
Renown South Meadows Medical Center
Reno, Nevada, 89521, United States
UniMed Center
East Brunswick, New Jersey, 08816, United States
IMA Clinical Research
Albuquerque, New Mexico, 87109, United States
Albany Stratton VA Medical Center
Albany, New York, 12208, United States
Meridian Clinical Research, LLC
Binghamton, New York, 13905, United States
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
IMA Clinical Research Westchester
Hartsdale, New York, 10530, United States
NYC Research INC
Long Island City, New York, 11106, United States
Mid Hudson Medical Research
New Windsor, New York, 12553, United States
IMA Clinical Research Manhattan
New York, New York, 10036, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Care Access - Fayetteville
Fayetteville, North Carolina, 28314, United States
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
Carolina Research Center
Shelby, North Carolina, 28150, United States
Accellacare - Piedmont
Statesville, North Carolina, 28625, United States
Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina, 28401, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213, United States
Remington-Davis, Inc
Columbus, Ohio, 43215, United States
Tekton Research, Inc
Moore, Oklahoma, 73160, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Northwest Research Center
Portland, Oregon, 97202, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Capital Area Research - Newport
Newport, Pennsylvania, 17074, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
The Research Center of The Upstate
Greenville, South Carolina, 29607, United States
Care Access - Mauldin
Mauldin, South Carolina, 29662, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749, United States
South Texas Clinical Research
Corpus Christi, Texas, 78404, United States
Thyroid, Endocrinology, and Diabetes
Dallas, Texas, 75208, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Cardio Voyage
Denison, Texas, 75020, United States
Soma Clinical Trials
Denison, Texas, 75020, United States
Care United Research
Forney, Texas, 75126, United States
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, 76132, United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164, United States
Victorium Clinical Research - Houston
Houston, Texas, 77024, United States
Juno Research
Houston, Texas, 77040, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
Research Physicians Network, LLC
Houston, Texas, 77089, United States
Biopharma Informatic, LLC
McAllen, Texas, 78503, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Audie L Murphy VA Hospital
San Antonio, Texas, 78229, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
VIP Trials
San Antonio, Texas, 78230, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Sherman Clinical Research
Sherman, Texas, 75090, United States
Northwest Houston Heart Center
Tomball, Texas, 77375, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Soma Clinical Trials
Wylie, Texas, 75098, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088, United States
Kalo Clinical Research
West Valley City, Utah, 84120, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Virginia Research Center
Midlothian, Virginia, 23114, United States
Eastern Virginia Medical School (EVMS) Strelitz Diabetes Research Center
Norfolk, Virginia, 23510, United States
Centricity Research Suffolk Family Medicine
Suffolk, Virginia, 23435, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
MultiCare Rockwood Clinic- Main
Spokane, Washington, 99202, United States
Universal Research Group
Tacoma, Washington, 98405, United States
St. Vincent Hospital d/b/a Prevea Health
Green Bay, Wisconsin, 54303, United States
Clinical Investigation Specialists
Kenosha, Wisconsin, 53144, United States
Buenos Aires Macula S.A
Buenos Aires, 1061, Argentina
CEMEDIC
Buenos Aires, 1407, Argentina
Centro Privado de Medicina Familiar / Mindout Research
Buenos Aires, 1417, Argentina
Cardiología Palermo
Buenos Aires, 1425, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
Glenny Corp. S.A.
Buenos Aires, C1430CKE, Argentina
CENUDIAB
Buenos Aires, C1440AAD, Argentina
Organizacion Medica de Investigacion
CABA, C1015ABO, Argentina
Hospital San Roque
Córdoba, 5000, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
Polo de Salud Vistalba
Lujan de Cuyo, 5509, Argentina
Instituto Médico Catamarca IMEC
Rosario, 2000, Argentina
Investigaciones Clínicas Tucumán
San Miguel de Tucumán, 4000, Argentina
Krankenhaus St. Josef Braunau
Braunau am Inn, 5280, Austria
VIVIT
Feldkirch, 6800, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Konventhospital der Barmherzigen Brüder Linz
Linz, 4021, Austria
Private Practice - Dr. Evelyn Fliesser-Gorzer
Sankt Stefan ob Stainz, 8511, Austria
Klinik Landstraße
Vienna, 1030, Austria
Zentrum für klinische Studien Dr Hanusch Gmbh
Vienna, 1060, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Klinik Hietzing
Vienna, 1130, Austria
Centro de Pesquisa Clinica do Coracao
Acaraju, 49055-530, Brazil
Centro de Pesquisa Clinica do Brasil
Brasília, 71625-175, Brazil
Hospital Brasilia
Brasília, 71681-603, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080, Brazil
Centro de Pesquisa Sao Lucas
Campinas, 13060-803, Brazil
Loema Instituto de Pesquisa Clinica
Campinas, 13092-133, Brazil
Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE
Fortaleza, 60160-230, Brazil
Hospital Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, 90430-001, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, 12243-280, Brazil
CPCLIN
São Paulo, 01228-200, Brazil
NotreDame Intermedica Saude S.A
São Paulo, 01229-010, Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030, Brazil
Hospital 9 De Julho
São Paulo, 01409-902, Brazil
Instituto Dante Pazzanese de Cardiology
São Paulo, 04012-909, Brazil
CEDOES
Vitória, 29055450, Brazil
Diacentrum Brandys n.L. s.r.o.
Brandýs nad Labem, 25001, Czechia
EFERTUS healthcare s.r.o.
Brno-Židenice, 615 00, Czechia
EDUMED - Broumov
Broumov, 550 01, Czechia
Nemocnice Cesky Krumlov
Český Krumlov, 381 01, Czechia
AIDIN VK s.r.o.
Hranice, 753 01, Czechia
EDUMED - Jaroměř
Jaroměř, 551 01, Czechia
MUDr. Tomas Edelsberger
Krnov, 79401, Czechia
EDUMED - Náchod
Náchod, 547 01, Czechia
PreventaMed
Olomouc, 779 00, Czechia
Private Practice - Dr. Miroslav Koliba
Ostrava, 702 00, Czechia
Diahelp s.r.o
Pardubice V, 530 02, Czechia
Dialine - Interni a diabetologicka ambulance
Pilsen, 301 00, Czechia
DiaVize s.r.o.
Prague, 140 00, Czechia
MEDICON
Prague, 140 00, Czechia
MUDr. Michala Pelikanova s.r.o.
Prague, 140 00, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, 14900, Czechia
EUC Klinika Praha
Prague, 150 00, Czechia
Praglandia s.r.o
Prague, 150 00, Czechia
FLEDIP s.r.o.
Prague, 160 00, Czechia
Nefromed
Prague, 160 00, Czechia
MUDr. Barbora Diepoltova
Praha 9 - Klanovice, 190 14, Czechia
Diabetespraxis Dr. Braun
Berlin, 13187, Germany
Gemeinschaftspraxis für Diabetologie
Eisenach, 99817, Germany
Praxis am Markt - Dr. Bernd Becker
Essen, 45355, Germany
MVZ im Altstadt-Carree Fulda GmbH
Fulda, 36037, Germany
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
Hof, 95030, Germany
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
Leipzig, 04249, Germany
SMO.MD GmbH
Magdeburg, 39120, Germany
Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
Mühldorf, 84453, Germany
RED-Institut GmbH
Oldenburg, 23758, Germany
Diabetologische Schwerpunktpraxis Marck Linn Pickel
Pohlheim, 35415, Germany
Praxis Dr. Veronika Wenzl-Bauer
Rehlingen, 66780, Germany
General Hospital of Athens "G. Gennimatas"
Athens, 11527, Greece
General Hospital of Athens Laiko
Athens, 11527, Greece
Attikon General University Hospital
Chaïdári, 12462, Greece
General Hospital of Lamia
Lamia, 351 00, Greece
Iatriko Paleou Falirou Medical Center
Palaió Fáliro, 17562, Greece
G. Gennimatas General Hospital of Thessaloniki
Thessaloniki, 546 35, Greece
V.S. General Hospital
Ahmedabad, 380006, India
Victoria Hospital, Bangalore Medical College And Research Institute
Bangalore, 560002, India
Life Care Hospital and Research Centre
Bangalore, 560092, India
S C B Medical College and Hospital
Cuttack, 753001, India
Apollo Excelcare Hospital
Guwahati, 781033, India
Karnataka Institute of Medical Sciences
Hubli, 580021, India
Eternal Heart Care Center and Research Institute
Jaipur, 302020, India
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai, 400012, India
Central India Cardiology and Research Institute
Nagpur, 440015, India
Chellaram Diabetes Institute
Pune, 411021, India
Nirmal Hospital Pvt Ltd.
Surat, 395002, India
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127, Italy
AOU Renato Dulbecco
Catanzaro, 88100, Italy
Università degli Studi Gabriele D' Annunzio
Chieti, 66100, Italy
Ospedale San Raffaele
Milan, 20132, Italy
University of Naples Federico II
Naples, 80100, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100, Italy
AO Santa Maria della Misericordia
Perugia, 06132, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168, Italy
Azienda Ospedaliero Universitaria Senese
Siena, 53100, Italy
Azienda sanitaria universitaria giuliano isontina ASUGI Ospedale Maggiore- Università di Trieste
Trieste, 34125, Italy
Clínica San Cosme
Aguascalientes, 20124, Mexico
Centro de Investigación Cardiometabólica de Aguascalientes
Aguascalientes, 20230, Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, 31217, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, 89440, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, 80230, Mexico
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango, 34000, Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, 44130, Mexico
Private Practice - Dr. Francisco Gerardo Padilla
Guadalajara, 44670, Mexico
Instituto Cardiovascular de León S.C.
León, 37520, Mexico
Cardiolink Clin Trials
Monterrey, 64060, Mexico
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro, 76000, Mexico
Centro de Investigacion Cardiovascular y Metabólica
Tijuana, 22500, Mexico
Centro de Endocrinologia y Nutricion
Caguas, 00725, Puerto Rico
Dorado Medical Complex
Dorado, 00646, Puerto Rico
Manati Center for Clinical Research
Manati, 00674, Puerto Rico
Puerto Rico Medical Research
Ponce, 00717, Puerto Rico
Research and Cardiovascular Corp.
Ponce, 00717, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
Mgcendo Llc
San Juan, 00921, Puerto Rico
Wellness clinical Research Vega Baja
Vega Baja, 00694, Puerto Rico
CMI Dr.Pletea Noemi SRL
Bacau, 600154, Romania
SC Minimed SRL
Bacau, 600274, Romania
Mariodiab Clinic
Brasov, 500097, Romania
C.M.D.T.A. Neomed
Brasov, 500283, Romania
Nicodiab
Bucharest, 010507, Romania
Geea Medical Easy Diet
Bucharest, 010627, Romania
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
Bucharest, 011053, Romania
Centrul Medical NutriLife
Bucharest, 013764, Romania
Centrul Medical Endocrinologie si Diabet Dr. Paveliu
Bucharest, 50538, Romania
Milena Sante
Galați, 800001, Romania
Diamed Obesity
Galați, 800291, Romania
Centrul Medical Consultmed
Iași, 700547, Romania
Cardiomed Iași
Iași, 700732, Romania
Diabdana
Oradea, 410147, Romania
Centrul Medical Grandmed
Oradea, 410159, Romania
Diabmed Dr. Popescu Alexandrina
Ploieşti, 100169, Romania
Clinica Korall
Satu Mare, 440055, Romania
Centrul Medical Mediab
Târgu Mureş, 540142, Romania
Cabinet Medical Dr.Geru
Timișoara, 300288, Romania
Diacrin s.r.o.
Bratislava, 831 01, Slovakia
Diab - Int
Bytča, 014 01, Slovakia
Human Care s.r.o.
Košice, 04001, Slovakia
IN-DIA
Lučenec, 984 01, Slovakia
NEDÚ - Národný endokrinologický a diabetologický ústav n.o.
Ľubochňa, 034 91, Slovakia
MediVet s.r.o.
Malacky, 901 01, Slovakia
DIA-MED CENTRUM s.r.o.
Púchov, 020 01, Slovakia
Tatratrial s.r.o.
Rožňava, 04801, Slovakia
MEDI-DIA s.r.o.
Sabinov, 083 01, Slovakia
Areteus s.r.o.
Trebišov, 075 01, Slovakia
JAL
Trnava, 917 01, Slovakia
Eulji University Hospital
Daejeon, 01830, South Korea
Hanyang University Guri Hospital
Guri-si, 11923, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, 01830, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitario de La Ribera
Alzira, 46600, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Complejo Hospitalario Ruber Juan Bravo
Madrid, 28006, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital General de Segovia
Segovia, 40002, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Vithas Hospital Sevilla
Seville, 41950, Spain
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 06230, Turkey (Türkiye)
Adnan Menderes University Medical Faculty
Aydin, 09100, Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, 21100, Turkey (Türkiye)
Erciyes University Medical Faculty
Kayseri, 38030, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi
Malatya, 44280, Turkey (Türkiye)
Mersin University
Mersin, 33343, Turkey (Türkiye)
Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre
Pamukkale, 20070, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center
Yüreğir, 01250, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 7, 2023
Study Start
April 3, 2023
Primary Completion
March 16, 2026
Study Completion
March 16, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.