AzTrials
AzTrials

Type 2 DiabetesPhase 3ACHIEVE-4NCT05803421

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

A Phase 3 study testing Orforglipron and Insulin Glargine in people with Type 2 Diabetes and Obesity, run by Eli Lilly and Company at 358 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Obesity, Overweight or Obesity
What is being tested?
Orforglipron and Insulin Glargine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,749 participants
Where
358 sitesin 16 countries
Study dates
3 Apr 2023to 16 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

358 sites in 16 countries.

358 sites in 16 countries

United States173 sites

  • Albany Stratton VA Medical Center

    Albany, New York, 12208

  • IMA Clinical Research

    Albuquerque, New Mexico, 87109

  • Orlando Heart & Vascular Institute

    Altamonte Springs, Florida, 32714

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78749

  • American Health Network of Indiana, LLC - Avon

    Avon, Indiana, 46123

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Meridian Clinical Research, LLC

    Binghamton, New York, 13905

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Qualmedica Research

    Bowling Green, Kentucky, 42101

  • SUNY Downstate Health Sciences University

    Brooklyn, New York, 11203

  • Investigators Research Group

    Brownsburg, Indiana, 46112

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303

  • The Institute for Liver Health

    Chandler, Arizona, 85224

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Diabetes and Endocrinology Specialists

    Chesterfield, Missouri, 63017

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Legacy Clinical Trials

    Colorado Springs, Colorado, 80909

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213

  • Remington-Davis, Inc

    Columbus, Ohio, 43215

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

  • Valley Clinical Trials, Inc.

    Covina, California, 91723

  • Louisiana Heart Center - Convington

    Covington, Louisiana, 70433

  • Midwest CRC

    Crystal Lake, Illinois, 60012

  • Thyroid, Endocrinology, and Diabetes

    Dallas, Texas, 75208

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Alliance for Multispecialty Research, LLC

    Daphne, Alabama, 36526

  • Revival Research Institute

    Dearborn, Michigan, 48126

  • Cardio Voyage

    Denison, Texas, 75020

  • Soma Clinical Trials

    Denison, Texas, 75020

  • UniMed Center

    East Brunswick, New Jersey, 08816

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York, 13057

  • Velocity Clinical Research, New Smyrna Beach

    Edgewater, Florida, 32132

  • Neighborhood Healthcare Institute of Health

    Escondido, California, 92025

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715

  • Lillestol Research

    Fargo, North Dakota, 58104

  • SKY Clinical Research Network Group - Hall

    Fayette, Mississippi, 39069

  • Care Access - Fayetteville

    Fayetteville, North Carolina, 28314

  • Care United Research

    Forney, Texas, 75126

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912

  • Diabetes and Thyroid Center of Ft. Worth

    Fort Worth, Texas, 76132

  • Valley Institute of Research - Fort Worth

    Fort Worth, Texas, 76164

  • American Health Network of Indiana, LLC - Franklin

    Franklin, Indiana, 46131

  • Valley Research

    Fresno, California, 93720

  • St. Vincent Hospital d/b/a Prevea Health

    Green Bay, Wisconsin, 54303

  • American Health Network of Indiana, LLC - Greenfield

    Greenfield, Indiana, 46140

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina, 27408

  • The Research Center of The Upstate

    Greenville, South Carolina, 29607

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • IMA Clinical Research Westchester

    Hartsdale, New York, 10530

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • Victorium Clinical Research - Houston

    Houston, Texas, 77024

  • Juno Research

    Houston, Texas, 77040

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Endocrine Ips, Pllc

    Houston, Texas, 77079

  • Research Physicians Network, LLC

    Houston, Texas, 77089

  • Nature Coast Clinical Research - Inverness

    Inverness, Florida, 34452

  • University of Iowa

    Iowa City, Iowa, 52242

  • Northeast Research Institute - Downtown Office

    Jacksonville, Florida, 32204

  • Logan Health Research

    Kalispell, Montana, 59901

  • Clinical Investigation Specialists

    Kenosha, Wisconsin, 53144

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

  • Care Access - Lake Charles (Bayou Pines)

    Lake Charles, Louisiana, 70601

  • Orange County Research Center

    Lake Forest, California, 92630

  • Clinical Research of Central Florida

    Lakeland, Florida, 33805

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Palm Research Center Sunset

    Las Vegas, Nevada, 89148

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia, 30046

  • Clinical Site Partners Leesburg

    Leesburg, Florida, 34748

  • KLR Business Group, Inc. dba Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Ark Clinical Research

    Long Beach, California, 90815

  • NYC Research INC

    Long Island City, New York, 11106

  • Pacific Clinical Studies

    Los Alamitos, California, 90720

  • Velocity Clinical Research, Los Angeles

    Los Angeles, California, 90017

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • The Jones Center Clinical Research

    Macon, Georgia, 31210

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Care Access - Mauldin

    Mauldin, South Carolina, 29662

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503

  • Aventiv Research

    Mesa, Arizona, 85206

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • L&C Professional Medical Research Institute

    Miami, Florida, 33144

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Virginia Research Center

    Midlothian, Virginia, 23114

  • Montana Medical Research

    Missoula, Montana, 59808

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608

  • Tekton Research, Inc

    Moore, Oklahoma, 73160

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557

  • Adult Medicine of Lake County

    Mt. Dora, Florida, 32757

  • American Health Network of Indiana, LLC - Muncie

    Muncie, Indiana, 47304

  • Saltzer Health

    Nampa, Idaho, 83686

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • IMA Clinical Research Manhattan

    New York, New York, 10036

  • Capital Area Research - Newport

    Newport, Pennsylvania, 17074

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114

  • Infinity Clinical Research - Norco

    Norco, California, 92860

  • Eastern Virginia Medical School (EVMS) Strelitz Diabetes Research Center

    Norfolk, Virginia, 23510

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • AMR Clinical

    Oak Brook, Illinois, 60523

  • Renstar Medical Research

    Ocala, Florida, 34470

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Cahaba Research - Pelham

    Pelham, Alabama, 35124

  • Arizona Liver Health - Peoria

    Peoria, Arizona, 85381

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Absolute Clinical Research

    Phoenix, Arizona, 85051

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

    Pittsburgh, Pennsylvania, 15243

  • Northwest Research Center

    Portland, Oregon, 97202

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730

  • Eastside Research Associates

    Redmond, Washington, 98052

  • Northern Nevada Endocrinology

    Reno, Nevada, 89511

  • Renown South Meadows Medical Center

    Reno, Nevada, 89521

  • Elite Clinical Trials

    Rexburg, Idaho, 83440

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Audie L Murphy VA Hospital

    San Antonio, Texas, 78229

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • VIP Trials

    San Antonio, Texas, 78230

  • LCGK Research

    San Carlos, California, 94070

  • Norcal Endocrinology & Internal Medicine

    San Ramon, California, 94583

  • Velocity Clinical Research, Coastal Heart Medical Group

    Santa Ana, California, 92704

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Syed Research Consultants Llc

    Sheffield, Alabama, 35660

  • Carolina Research Center

    Shelby, North Carolina, 28150

  • Sherman Clinical Research

    Sherman, Texas, 75090

  • NorthShore University Health System

    Skokie, Illinois, 60077

  • MultiCare Rockwood Clinic- Main

    Spokane, Washington, 99202

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Accellacare - Piedmont

    Statesville, North Carolina, 28625

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Centricity Research Suffolk Family Medicine

    Suffolk, Virginia, 23435

  • Clinical Research Institute of Arizona (CRI) - Sun City West

    Sun City West, Arizona, 85375

  • Universal Research Group

    Tacoma, Washington, 98405

  • Better Life Clinical Research

    Tampa, Florida, 33607

  • Precision Research Center

    Tampa, Florida, 33614

  • Care Access - Tampa

    Tampa, Florida, 33625

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona, 85281

  • Northwest Houston Heart Center

    Tomball, Texas, 77375

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

  • Cotton O'Neil Mulvane

    Topeka, Kansas, 66606

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • Orange Grove Family Practice

    Tucson, Arizona, 85741

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Kalo Clinical Research

    West Valley City, Utah, 84120

  • Millennium Clinical Trials

    Westlake Village, California, 91361

  • Encore Medical Research - Weston

    Weston, Florida, 33331

  • Accellacare - Wilmington - 1917 Tradd Court

    Wilmington, North Carolina, 28401

  • Conquest Research

    Winter Park, Florida, 32789

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • Soma Clinical Trials

    Wylie, Texas, 75098

Other trials in United States

Czechia21 sites

  • Diacentrum Brandys n.L. s.r.o.

    Brandýs nad Labem, 25001

  • EFERTUS healthcare s.r.o.

    Brno-Židenice, 615 00

  • EDUMED - Broumov

    Broumov, 550 01

  • Nemocnice Cesky Krumlov

    Český Krumlov, 381 01

  • AIDIN VK s.r.o.

    Hranice, 753 01

  • EDUMED - Jaroměř

    Jaroměř, 551 01

  • MUDr. Tomas Edelsberger

    Krnov, 79401

  • EDUMED - Náchod

    Náchod, 547 01

  • PreventaMed

    Olomouc, 779 00

  • Private Practice - Dr. Miroslav Koliba

    Ostrava, 702 00

  • Diahelp s.r.o

    Pardubice V, 530 02

  • Dialine - Interni a diabetologicka ambulance

    Pilsen, 301 00

  • DiaVize s.r.o.

    Prague, 140 00

  • MEDICON

    Prague, 140 00

  • MUDr. Michala Pelikanova s.r.o.

    Prague, 140 00

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague, 14900

  • EUC Klinika Praha

    Prague, 150 00

  • Praglandia s.r.o

    Prague, 150 00

  • FLEDIP s.r.o.

    Prague, 160 00

  • Nefromed

    Prague, 160 00

  • MUDr. Barbora Diepoltova

    Praha 9 - Klanovice, 190 14

Other trials in Czechia

Romania19 sites

  • CMI Dr.Pletea Noemi SRL

    Bacau, 600154

  • SC Minimed SRL

    Bacau, 600274

  • Mariodiab Clinic

    Brasov, 500097

  • C.M.D.T.A. Neomed

    Brasov, 500283

  • Nicodiab

    Bucharest, 010507

  • Geea Medical Easy Diet

    Bucharest, 010627

  • Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului

    Bucharest, 011053

  • Centrul Medical NutriLife

    Bucharest, 013764

  • Centrul Medical Endocrinologie si Diabet Dr. Paveliu

    Bucharest, 50538

  • Milena Sante

    Galați, 800001

  • Diamed Obesity

    Galați, 800291

  • Centrul Medical Consultmed

    Iași, 700547

  • Cardiomed Iași

    Iași, 700732

  • Diabdana

    Oradea, 410147

  • Centrul Medical Grandmed

    Oradea, 410159

  • Diabmed Dr. Popescu Alexandrina

    Ploieşti, 100169

  • Clinica Korall

    Satu Mare, 440055

  • Centrul Medical Mediab

    Târgu Mureş, 540142

  • Cabinet Medical Dr.Geru

    Timișoara, 300288

Other trials in Romania

Brazil18 sites

  • Centro de Pesquisa Clinica do Coracao

    Acaraju, 49055-530

  • Centro de Pesquisa Clinica do Brasil

    Brasília, 71625-175

  • Hospital Brasilia

    Brasília, 71681-603

  • Instituto de Pesquisa clinica de Campinas

    Campinas, 13060-080

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803

  • Loema Instituto de Pesquisa Clinica

    Campinas, 13092-133

  • Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE

    Fortaleza, 60160-230

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, 90430-001

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180

  • Pesquisare Saude

    Santo André, 09080-110

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, 12243-280

  • CPCLIN

    São Paulo, 01228-200

  • NotreDame Intermedica Saude S.A

    São Paulo, 01229-010

  • BR Trials - Ensaios Clinicos e Consultoria

    São Paulo, 01236030

  • Hospital 9 De Julho

    São Paulo, 01409-902

  • Instituto Dante Pazzanese de Cardiology

    São Paulo, 04012-909

  • CEDOES

    Vitória, 29055450

Other trials in Brazil

Argentina16 sites

  • Buenos Aires Macula S.A

    Buenos Aires, 1061

  • CEMEDIC

    Buenos Aires, 1407

  • Centro Privado de Medicina Familiar / Mindout Research

    Buenos Aires, 1417

  • Cardiología Palermo

    Buenos Aires, 1425

  • CIPREC

    Buenos Aires, C1061AAS

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC

  • Glenny Corp. S.A.

    Buenos Aires, C1430CKE

  • CENUDIAB

    Buenos Aires, C1440AAD

  • Organizacion Medica de Investigacion

    CABA, C1015ABO

  • Hospital San Roque

    Córdoba, 5000

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, 2152

  • Polo de Salud Vistalba

    Lujan de Cuyo, 5509

  • Instituto Médico Catamarca IMEC

    Rosario, 2000

  • Investigaciones Clínicas Tucumán

    San Miguel de Tucumán, 4000

Other trials in Argentina

South Korea13 sites

  • Eulji University Hospital

    Daejeon, 01830

  • Hanyang University Guri Hospital

    Guri-si, 11923

  • Yeungnam Univeristy Medical Center

    Gyeongsan-si, 42415

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, 06591

  • Ulsan University Hospital

    Ulsan, 44033

  • Wonju Severance Christian Hospital

    Wŏnju, 26426

  • Yonsei University-Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Mexico12 sites

  • Clínica San Cosme

    Aguascalientes, 20124

  • Centro de Investigación Cardiometabólica de Aguascalientes

    Aguascalientes, 20230

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua City, 31217

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Ciudad Madero, 89440

  • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

    Culiacán, 80230

  • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

    Durango, 34000

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, 44130

  • Private Practice - Dr. Francisco Gerardo Padilla

    Guadalajara, 44670

  • Instituto Cardiovascular de León S.C.

    León, 37520

  • Cardiolink Clin Trials

    Monterrey, 64060

  • Centro de Estudios Clínicos de Querétaro (CECLIQ)

    Querétaro, 76000

  • Centro de Investigacion Cardiovascular y Metabólica

    Tijuana, 22500

Other trials in Mexico

Germany11 sites

  • Diabetespraxis Dr. Braun

    Berlin, 13187

  • Gemeinschaftspraxis für Diabetologie

    Eisenach, 99817

  • Praxis am Markt - Dr. Bernd Becker

    Essen, 45355

  • MVZ im Altstadt-Carree Fulda GmbH

    Fulda, 36037

  • Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel

    Hof, 95030

  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

    Leipzig, 04249

  • SMO.MD GmbH

    Magdeburg, 39120

  • Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte

    Mühldorf, 84453

  • RED-Institut GmbH

    Oldenburg, 23758

  • Diabetologische Schwerpunktpraxis Marck Linn Pickel

    Pohlheim, 35415

  • Praxis Dr. Veronika Wenzl-Bauer

    Rehlingen, 66780

Other trials in Germany

India11 sites

  • V.S. General Hospital

    Ahmedabad, 380006

  • Victoria Hospital, Bangalore Medical College And Research Institute

    Bangalore, 560002

  • Life Care Hospital and Research Centre

    Bangalore, 560092

  • S C B Medical College and Hospital

    Cuttack, 753001

  • Apollo Excelcare Hospital

    Guwahati, 781033

  • Karnataka Institute of Medical Sciences

    Hubli, 580021

  • Eternal Heart Care Center and Research Institute

    Jaipur, 302020

  • King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College

    Mumbai, 400012

  • Central India Cardiology and Research Institute

    Nagpur, 440015

  • Chellaram Diabetes Institute

    Pune, 411021

  • Nirmal Hospital Pvt Ltd.

    Surat, 395002

Other trials in India

Slovakia11 sites

  • Diacrin s.r.o.

    Bratislava, 831 01

  • Diab - Int

    Bytča, 014 01

  • Human Care s.r.o.

    Košice, 04001

  • NEDÚ - Národný endokrinologický a diabetologický ústav n.o.

    Ľubochňa, 034 91

  • IN-DIA

    Lučenec, 984 01

  • MediVet s.r.o.

    Malacky, 901 01

  • DIA-MED CENTRUM s.r.o.

    Púchov, 020 01

  • Tatratrial s.r.o.

    Rožňava, 04801

  • MEDI-DIA s.r.o.

    Sabinov, 083 01

  • Areteus s.r.o.

    Trebišov, 075 01

  • JAL

    Trnava, 917 01

Other trials in Slovakia

Spain11 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario de La Ribera

    Alzira, 46600

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid, 28006

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital General de Segovia

    Segovia, 40002

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Vithas Hospital Sevilla

    Seville, 41950

Other trials in Spain

Italy10 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • AOU Renato Dulbecco

    Catanzaro, 88100

  • Università degli Studi Gabriele D' Annunzio

    Chieti, 66100

  • Ospedale San Raffaele

    Milan, 20132

  • University of Naples Federico II

    Naples, 80100

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100

  • AO Santa Maria della Misericordia

    Perugia, 06132

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168

  • Azienda Ospedaliero Universitaria Senese

    Siena, 53100

  • Azienda sanitaria universitaria giuliano isontina ASUGI Ospedale Maggiore- Università di Trieste

    Trieste, 34125

Other trials in Italy

Austria9 sites

  • Krankenhaus St. Josef Braunau

    Braunau am Inn, 5280

  • VIVIT

    Feldkirch, 6800

  • Medizinische Universität Graz

    Graz, 8036

  • Konventhospital der Barmherzigen Brüder Linz

    Linz, 4021

  • Private Practice - Dr. Evelyn Fliesser-Gorzer

    Sankt Stefan ob Stainz, 8511

  • Klinik Landstraße

    Vienna, 1030

  • Zentrum für klinische Studien Dr Hanusch Gmbh

    Vienna, 1060

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

  • Klinik Hietzing

    Vienna, 1130

Other trials in Austria

Puerto Rico9 sites

  • Centro de Endocrinologia y Nutricion

    Caguas, 00725

  • Dorado Medical Complex

    Dorado, 00646

  • Manati Center for Clinical Research

    Manati, 00674

  • Puerto Rico Medical Research

    Ponce, 00717

  • Research and Cardiovascular Corp.

    Ponce, 00717

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

  • Mindful Medical Research

    San Juan, 00918

  • Mgcendo Llc

    San Juan, 00921

  • Wellness clinical Research Vega Baja

    Vega Baja, 00694

Other trials in Puerto Rico

Turkey (Türkiye)8 sites

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 06230

  • Adnan Menderes University Medical Faculty

    Aydin, 09100

  • Dicle Üniversitesi

    Diyarbakır, 21100

  • Erciyes University Medical Faculty

    Kayseri, 38030

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi

    Malatya, 44280

  • Mersin University

    Mersin, 33343

  • Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre

    Pamukkale, 20070

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Yüreğir, 01250

Other trials in Turkey (Türkiye)

Greece6 sites

  • General Hospital of Athens "G. Gennimatas"

    Athens, 11527

  • General Hospital of Athens Laiko

    Athens, 11527

  • Attikon General University Hospital

    Chaïdári, 12462

  • General Hospital of Lamia

    Lamia, 351 00

  • Iatriko Paleou Falirou Medical Center

    Palaió Fáliro, 17562

  • G. Gennimatas General Hospital of Thessaloniki

    Thessaloniki, 546 35

Other trials in Greece

About this study

Official title: 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

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.

Being tested
Orforglipron, Insulin Glargine
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight, Cardiovascular Diseases, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally once daily

  • Insulin GlargineDrug

    Administered SC once daily

Study groups in NCT05803421
Study groupRoleWhat they receive
OrforglipronExperimentalParticipants will receive escalated doses of orforglipron orally.
Receives: Drug: Orforglipron
Insulin GlargineActive comparatorParticipants will receive insulin glargine subcutaneously (SC). Doses will be individualized and titrated according to a treat-to-target algorithm.
Receives: Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline to End of the Study (Approximate Maximum 104 Weeks)

Secondary outcomes (9)

  1. Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)

    Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)

    Measured: Baseline to End of the Study (Approximately 104 Weeks)

  2. Change from Baseline in Hemoglobin A1c (HbA1c)

    Change from Baseline in HbA1c

    Measured: Baseline, Week 52

  3. Change from Baseline in Fasting Serum Glucose

    Change from Baseline in Fasting Serum Glucose

    Measured: Baseline, Week 52

  4. Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile

    Change from Baseline in Daily Average 7-point SMBG

    Measured: Baseline, Week 52

  5. Percentage of Participants with HbA1c Target Values Less Than (<)7.0% (53 mmol/mol)

    Percentage of Participants with HbA1c Target Values <7.0% (53 mmol/mol)

    Measured: Week 52

  6. Change from Baseline in Body Weight

    Change from Baseline in Body Weight

    Measured: Baseline, Week 52

  7. Percent Change from Baseline Body Weight

    Percent Change from Baseline Body Weight

    Measured: Week 52

  8. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score

    The SF-36v2 acute form is a 36-item generic, participant completed measure designed to assess 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores of each domain are measured by T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health.

    Measured: Baseline, Week 52

  9. Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron

    PK will be estimated based on the population PK model.

    Measured: Baseline through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start3 Apr 2023
  3. Primary completion16 Mar 2026
  4. Study completion16 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,749 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05803421
Sponsor's protocol ID
18563
Other IDs
J2A-MC-GZGS, 2022-502833-25-00, U1111-1285-6821
Acronym
ACHIEVE-4
Status last verified
Apr 2026
First submitted
27 Mar 2023
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Klein KR, Wysham C, Tuttle KR, Davies MJ, Cox D, Chen J, Wu WS, Denning M, Liu R, Ludwig L, Meskimen ER. Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trial. Lancet. 2026 Sep 30:S0140-6736(26)01865-9. doi: 10.1016/S0140-6736(26)01865-9. Online ahead of print.

    PubMed 42815506

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron and Insulin Glargine in people with Type 2 Diabetes and Obesity, run by Eli Lilly and Company at 358 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 358 sites in United States, Czechia, Romania, Brazil, Argentina and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 frame: Baseline to End of the Study (Approximate Maximum 104 Weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05803421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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