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

Obesity Clinical Trial

— ACHIEVE-4  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803421
• Other study ID #: 18563
• Secondary ID: J2A-MC-GZGS2022-
• Status: Recruiting
• Phase: Phase 3
• Start date: April 3, 2023
• Est. completion date: December 17, 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2620
• Est. completion date: December 17, 2025
• Est. primary completion date: April 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Obesity
• Overweight
• Overweight or Obesity
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Drug:
• Orforglipron
Administered orally once daily
• Insulin Glargine
Administered SC once daily

Locations

Country	Name	City	State
Argentina	Buenos Aires Macula S.A	Buenos Aires
Argentina	Cardiología Palermo	Buenos Aires
Argentina	CEMEDIC	Buenos Aires
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	Glenny Corp	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Organizacion Medica de Investigacion	Caba	Buenos Aires
Argentina	Centro Privado de Medicina Familiar / Mindout Research	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	CENUDIAB	Ciudad Autónoma de Buenos Aire
Argentina	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)	Córdoba
Argentina	Hospital San Roque	Córdoba
Argentina	Centro de Investigaciones Clínicas Baigorria	Granadero Baigorria	Santa Fe
Argentina	Polo de Salud Vistalba	Luján de Cuyo	Mendoza
Argentina	Instituto Médico Catamarca IMEC	Rosario	Santa Fe
Argentina	Investigaciones Clínicas Tucumán	San Miguel de Tucuman	Tucumán
Austria	Krankenhaus St. Josef Braunau	Braunau	Oberösterreich
Austria	VIVIT	Feldkirch	Vorarlberg
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Medizinische Universitaet Innsbruck	Innsbruck	Tirol
Austria	Konventhospital der Barmherzigen Brüder Linz	Linz	Oberösterreich
Austria	Private Practice - Dr. Evelyn Fliesser-Gorzer	Sankt Stefan ob Stainz
Austria	Medizinische Universität Wien	Vienna	Wien
Austria	Zentrum für klinische Studien Dr Hanusch Gmbh	Vienna	Wien
Austria	Klinik Hietzing	Wien
Austria	Klinik Landstraße	Wien
Brazil	Centro de Pesquisa Clinica do Coracao	Acaraju	Sergipe
Brazil	Centro de Pesquisa Clinica do Brasil	Brasilia	Distrito Federal
Brazil	Hospital Brasilia	Brasilia	Distrito Federal
Brazil	Centro de Pesquisa Sao Lucas	Campinas	São Paulo
Brazil	Instituto de Pesquisa clinica de Campinas	Campinas	São Paulo
Brazil	Loema Instituto de Pesquisa Clinica	Campinas	São Paulo
Brazil	Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE	Fortaleza	Ceará
Brazil	CPHOSP Manaus Medicina, Ensino e Pesquisa	Manaus	Amazonas
Brazil	CPCLIN	Natal	Rio Grande Do Norte
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	IBPClin - Instituto Brasil de Pesquisa Clínica	Rio de Janeiro
Brazil	Pesquisare Saude	Santo André	São Paulo
Brazil	ISPEM - Instituto São José dos Campos em Pesquisas Médicas	São José dos Campos	São Paulo
Brazil	BR Trials - Ensaios Clinicos e Consultoria	São Paulo
Brazil	Hospital 9 De Julho	São Paulo
Brazil	Instituto Dante Pazzanese de Cardiology	São Paulo
Brazil	NotreDame Intermedica Saude S.A	São Paulo
Brazil	CEDOES	Vitória	Espírito Santo
Czechia	Diacentrum Brandys n.L. s.r.o.	Brandys nad Labem	Praha-východ
Czechia	EFERTUS healthcare s.r.o.	Brno-Bystrc	Brno-mesto
Czechia	EDUMED - Broumov	Broumov	Náchod
Czechia	Nemocnice Cesky Krumlov	Ceský Krumlov
Czechia	AIDIN VK s.r.o.	Hranice	Olomoucký Kraj
Czechia	EDUMED - Jaromer	Jaromer	Náchod
Czechia	MUDr. Tomas Edelsberger	Krnov	Moravskoslezský Kraj
Czechia	EDUMED - Náchod	Náchod
Czechia	PreventaMed	Olomouc
Czechia	Private Practice - Dr. Miroslav Koliba	Ostrava	Ostrava Mesto
Czechia	Diahelp s.r.o	Pardubice
Czechia	Dialine - Interni a diabetologicka ambulance	Pilsen
Czechia	FLEDIP s.r.o.	Prague	Praha, Hlavní Mešto
Czechia	MEDICON	Prague	Praha 4
Czechia	Nefromed	Prague	Praha 6
Czechia	EUC Klinika Praha	Prague 5	Praha 5
Czechia	Milan Kvapil s.r.o., Diabetologicka ambulance	Praha	Praha 4
Czechia	DiaVize s.r.o.	Praha 4	Praha, Hlavní Mešto
Czechia	MUDr. Michala Pelikanova s.r.o.	Praha 4
Czechia	Praglandia s.r.o	Praha 5
Czechia	MUDr. Barbora Diepoltova	Praha 9 - Klanovice	Praha 9
Czechia	Masarykova Nemocnice V Usti Nad Labem	Rumburk	Ústecký Kraj
Germany	Diabetespraxis Prenzlauer Alle	Berlin
Germany	Gemeinschaftspraxis für Diabetologie	Eisenach	Thüringen
Germany	Private Practice - Dr. Bernd Becker	Essen	Nordrhein-Westfalen
Germany	MVZ im Altstadt-Carree Fulda GmbH	Fulda
Germany	Diabetes Zentrum Dr. Tews	Gelnhausen
Germany	Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel	Hof
Germany	Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut	Leipzig	Sachsen
Germany	SMO.MD GmbH	Magdeburg	Sachsen-Anhalt
Germany	Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte	Mühldorf	Bayern
Germany	Medic-Center Nürnberg - Schöll & Kollegen	Nürnberg
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Diabetologische Schwerpunktpraxis Marck Linn Pickel	Pohlheim	Hessen
Germany	Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer null Josef Wenzl	Rehlingen
Germany	Hegau-Bodensee-Klinikum Singen	Singen (Hohentwiel)	Baden-Württemberg
Greece	General Hospital of Athens "G. Gennimatas"	Athens	Attikí
Greece	General Hospital of Athens Laiko	Athens	Attikí
Greece	Attikon General University Hospital	Chaidari	Attikí
Greece	General Hospital of Lamia	Lamia	Fthiótida
Greece	Iatriko Paleou Falirou Medical Center	Paleo Faliro	Attikí (Region)
Greece	G. Gennimatas General Hospital of Thessaloniki	Thessaloniki
India	V.S. General Hospital	Ahmedabad	Gujarat
India	Life Care Hospital and Research Centre	Bangalore	Karnataka
India	Victoria Hospital, Bangalore Medical College And Research Institute	Bangalore	Karnataka
India	S C B Medical College and Hospital	Cuttack	Odisha
India	Apollo Excelcare Hospital	Guwahati	Assam
India	Karnataka Institute of Medical Sciences	Hubli	Karnataka
India	Eternal Heart Care Center and Research Institute	Jaipur	Rajasthan
India	Sawai Man Singh Medical College Hospital (SMS Hospital)	Jaipur	Rajasthan
India	King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College	Mumbai	Maharashtra
India	Central India Cardiology and Research Institute	Nagpur	Maharashtra
India	Chellaram Diabetes Institute	Pune	Maharashtra
India	Nirmal Hospital	Surat	Gujarat
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliera Mater Domini	Catanzaro
Italy	Università degli Studi Gabriele D' Annunzio	Chieti	Abruzzo
Italy	Ospedale San Raffaele	Milano
Italy	University of Naples Federico II	Naples	Campania
Italy	Azienda Ospedaliero Universitaria Maggiore della Carità	Novara
Italy	AO Santa Maria della Misericordia	Perugia	Umbria
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Italy	Ospedale Le Scotte	Siena	Toscana
Italy	Azienda sanitaria universitaria giuliano isontina ASUGI Ospedale Maggiore- Università di Trieste	Trieste	Friuli-Venezia Giulia
Korea, Republic of	Eulji University Hospital	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Kyonggi-do
Korea, Republic of	Yeungnam Univeristy Medical Center	Gyeongsan-si	Kyongsangbuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teuk
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Ulsan University Hospital	Ulsan	Ulsan-Kwangyokshi
Korea, Republic of	Yonsei University-Wonju Severance Christian Hospital	Wonju	Kang-won-do
Korea, Republic of	Yonsei University-Wonju Severance Christian Hospital	Wonju	Kang-won-d
Mexico	Centro de Investigación Cardiometabólica de Aguascalientes	Aguascalientes
Mexico	Clínica San Cosme	Aguascalientes
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Ciudad Madero	Tamaulipas
Mexico	Instituto de Diabetes, Obesidad y Nutricion	Cuernavaca	Morelos
Mexico	Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.	Culiacán	Sinaloa
Mexico	Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia	Durango
Mexico	Diseno y Planeacion en Investigacion Medica	Guadalajara	Jalisco
Mexico	Private Practice - Dr. Francisco Gerardo Padilla	Guadalajara	Jalisco
Mexico	Instituto Cardiovascular de León S.C.	León	Guanajuato
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Cardiolink Clin Trials	Monterrey	Nuevo León
Mexico	Unidad biomedica avanzada monterrey	Monterrey	Nuevo León
Mexico	Centro de Estudios Clínicos de Querétaro (CECLIQ)	Querétaro
Mexico	Centro de Investigacion Cardiovascular y Metabólica	Tijuana	Baja California
Puerto Rico	Centro de Endocrinologia y Nutricion	Caguas
Puerto Rico	Dorado Medical Complex	Dorado
Puerto Rico	Manati Center for Clinical Research	Manati
Puerto Rico	Puerto Rico Medical Research	Ponce
Puerto Rico	Research and Cardiovascular Corp.	Ponce
Puerto Rico	Endocrinologist Metabolic Clinic & Research Institute	San Juan
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Puerto Rico	Mindful Medical Research	San Juan
Puerto Rico	Wellness clinical Research Vega Baja	Vega Baja
Romania	CMI Dr.Pletea Noemi SRL	Bacau
Romania	SC Minimed SRL	Bacau
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	Mariodiab Clinic	Brasov	Bra?ov
Romania	Centrul Medical Endocrinologie si Diabet Dr. Paveliu	Bucharest	Bucure?ti
Romania	Centrul Medical NutriLife	Bucharest	Bucure?ti
Romania	Geea Medical Easy Diet	Bucharest	Bucure?ti
Romania	Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului	Bucharest	Bucure?ti
Romania	Nicodiab	Bucharest	Bucure?ti
Romania	Diamed Obesity	Gala?i
Romania	Milena Sante	Gala?i
Romania	Cardiomed Ia?i	Ia?i
Romania	Centrul Medical Consultmed	Ia?i
Romania	Centrul Medical Grandmed	Oradea	Bihor
Romania	Diabdana	Oradea	Bihor
Romania	Diabmed Dr. Popescu Alexandrina	Ploie?ti	Prahova
Romania	Clinica Korall	Satu Mare
Romania	Centrul Medical Mediab	Târgu-Mure?	Mure?
Romania	Cabinet Medical Dr.Geru	Timisoara	Timi?
Slovakia	Metabol KLINIK	Bratislava	Bratislavský Kraj
Slovakia	Diab - Int	Bytca	Žilinský Kraj
Slovakia	Human Care s.r.o.	Kosice	Košický Kraj
Slovakia	NEDÚ - Národný endokrinologický a diabetologický ústav n.o.	Lubochna	Žilinský Kraj
Slovakia	IN-DIA	Lucenec	Banskobystrický Kraj
Slovakia	MediVet s.r.o.	Malacky	Bratislavský Kraj
Slovakia	DIA-MED CENTRUM s.r.o.	Puchov	Trenciansky Kraj
Slovakia	Diacrin .s.ro.	Puchov	Trenciansky Kraj
Slovakia	Tatratrial s.r.o.	Rožnava	Košický Kraj
Slovakia	MEDI-DIA s.r.o.	Sabinov	Prešovský Kraj
Slovakia	Areteus s.r.o.	Trebisov	Košický Kraj
Slovakia	JAL	Trnava
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [La Coruña]
Spain	Hospital Universitario de La Ribera	Alzira	Valenciana, Comunitat
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Complejo Hospitalario Ruber Juan Bravo	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias, Principado De
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital General de Segovia	Segovia
Spain	Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)	Sevilla
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Vithas Hospital Sevilla	Seville	Sevilla
Turkey	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Aydin Adnan Menderes Universitesi Hastanesi	Aydin
Turkey	Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre	Denizli
Turkey	Dicle Üniversitesi	Diyarbakir
Turkey	Acibadem Universitesi Atakent Hastanesi	Istanbul
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Kadikoy	Istanbul
Turkey	Erciyes Universitesi Tip Fakultesi Hastaneleri	Kayseri
Turkey	Inönü Üniversitesi Turgut Özal Tip Merkezi	Malatya
Turkey	Mersin University	Mersin
Turkey	Baskent University Dr. Turgut Noyan Research and Training Center	Yuregir	Adana
United States	Albany Stratton VA Medical Center	Albany	New York
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	Orlando Heart & Vascular Institute	Altamonte Springs	Florida
United States	JEM Research Institute	Atlantis	Florida
United States	Rocky Mountain Regional VA Medical Center	Aurora	Colorado
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	American Health Network of IN, LLC	Avon	Indiana
United States	Maryland Cardiovascular Specialists	Baltimore	Maryland
United States	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania
United States	Meridian Clinical Research, LLC	Binghamton	New York
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Qualmedica Research	Bowling Green	Kentucky
United States	SUNY Downstate Health Sciences University	Brooklyn	New York
United States	Investigators Research Group	Brownsburg	Indiana
United States	Hope Clinical Research, Inc.	Canoga Park	California
United States	The Institute for Liver Health	Chandler	Arizona
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Diabetes and Endocrinology Specialists	Chesterfield	Missouri
United States	Legacy Clinical Trials	Colorado Springs	Colorado
United States	Remington Davis Clinical Research	Columbus	Ohio
United States	South Texas Clinical Research	Corpus Christi	Texas
United States	Valley Clinical Trials, Inc.	Covina	California
United States	Midwest CRC	Crystal Lake	Illinois
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Thyroid, Endocrinology, and Diabetes	Dallas	Texas
United States	Alliance for Multispecialty Research, LLC	Daphne	Alabama
United States	Revival Research Institute	Dearborn	Michigan
United States	Cardio Voyage	Denison	Texas
United States	Soma Clinical Trials	Denison	Texas
United States	Epic Medical Research - DeSoto	DeSoto	Texas
United States	Aventiv Research	Dublin	Ohio
United States	UniMed Center	East Brunswick	New Jersey
United States	Clarity Clinical Research	East Syracuse	New York
United States	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida
United States	Alliance for Multispecialty Research, LLC	El Dorado	Kansas
United States	Meridian Clinical Research, LLC	Endwell	New York
United States	Neighborhood Healthcare Institute of Health	Escondido	California
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Lillestol Research	Fargo	North Dakota
United States	SKY Clinical Research Network Group - Hall	Fayette	Mississippi
United States	Care Access - Fayetteville	Fayetteville	North Carolina
United States	Care United Research	Forney	Texas
United States	Alliance for Multispecialty Research, LLC	Fort Myers	Florida
United States	Diabetes and Thyroid Center of Ft. Worth	Fort Worth	Texas
United States	Valley Institute of Research - Fort Worth	Fort Worth	Texas
United States	American Health Network of IN, LLC	Franklin	Indiana
United States	Valley Research	Fresno	California
United States	St. Vincent Hospital d/b/a Prevea Health	Green Bay	Wisconsin
United States	NorCal Medical Research, Inc	Greenbrae	California
United States	American Health Network of IN, LLC	Greenfield	Indiana
United States	PharmQuest	Greensboro	North Carolina
United States	The Research Center of The Upstate	Greenville	South Carolina
United States	Great Lakes Clinical Trials - Gurnee	Gurnee	Illinois
United States	CMR of Greater New Haven, LLC	Hamden	Connecticut
United States	Louisiana Heart Center - Hammond	Hammond	Louisiana
United States	IMA Clinical Research - Hartsdale	Hartsdale	New York
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	Amir A Hassan, MD, PA	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Endocrine Ips, Pllc	Houston	Texas
United States	Juno Research	Houston	Texas
United States	Victorium Clinical Research - Houston	Houston	Texas
United States	Nature Coast Clinical Research - Inverness	Inverness	Florida
United States	University of Iowa	Iowa City	Iowa
United States	Northeast Research Institute - Downtown Office	Jacksonville	Florida
United States	Glacier View Research Institute - Endocrinology	Kalispell	Montana
United States	Clinical Investigation Specialists	Kenosha	Wisconsin
United States	Helios Clinical Research - KIS	Kissimmee	Florida
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	New Phase Research and Development	Knoxville	Tennessee
United States	Care Access - Lake Charles	Lake Charles	Louisiana
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Palm Research Center Sunset	Las Vegas	Nevada
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Sierra Clinical Research	Las Vegas	Nevada
United States	Balanced Life Health Care Solutions/SKYCRNG	Lawrenceville	Georgia
United States	Physicians Research Associates	Lawrenceville	Georgia
United States	Clinical Site Partners Leesburg	Leesburg	Florida
United States	KLR Business Group, Inc. dba Arkansas Clinical Research	Little Rock	Arkansas
United States	Ark Clinical Research	Long Beach	California
United States	NYC Research INC	Long Island City	New York
United States	Pacific Clinical Studies	Los Alamitos	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	East Coast Institute for Research at The Jones Center	Macon	Georgia
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Care Access - Mauldin	Mauldin	South Carolina
United States	Biopharma Informatic, LLC	McAllen	Texas
United States	Aventiv Research	Mesa	Arizona
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	L&C Professional Medical Research Institute	Miami	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Virginia Research Center	Midlothian	Virginia
United States	Montana Medical Research	Missoula	Montana
United States	Alliance for Multispecialty Research, LLC	Mobile	Alabama
United States	Tekton Research, Inc	Moore	Oklahoma
United States	Lucas Research, Inc	Morehead City	North Carolina
United States	Riverside University Health System - Medical Center	Moreno Valley	California
United States	Adult Medicine of Lake County	Mount Dora	Florida
United States	American Health Network of IN, LLC	Muncie	Indiana
United States	Avalon Medical Group	Muscle Shoals	Alabama
United States	Saltzer Health	Nampa	Idaho
United States	Alliance for Multispecialty Research, LLC	New Orleans	Louisiana
United States	Mid Hudson Medical Research	New Windsor	New York
United States	IMA Clinical Research	New York	New York
United States	Capital Area Research - Newport	Newport	Pennsylvania
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Infinity Clinical Research - Norco	Norco	California
United States	Eastern Virginia Medical School (EVMS) Strelitz Diabetes Research Center	Norfolk	Virginia
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	Velocity Clinical Research, North Hollywood	North Hollywood	California
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Affinity Health	Oak Brook	Illinois
United States	Renstar Medical Research	Ocala	Florida
United States	West Orange Endocrinology	Ocoee	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	Orange County Research Center	Orange	California
United States	Pasadena Clinical Research	Pasadena	California
United States	Cahaba Research - Pelham	Pelham	Alabama
United States	Arizona Liver Health - Peoria	Peoria	Arizona
United States	Clinical Research of Philadelphia	Philadelphia	Pennsylvania
United States	Absolute Clinical Research	Phoenix	Arizona
United States	Elite Clinical Studies	Phoenix	Arizona
United States	Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair	Pittsburgh	Pennsylvania
United States	Peace River Cardiovascular Center	Port Charlotte	Florida
United States	Northwest Research Center	Portland	Oregon
United States	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Monument Health Rapid City Hospital	Rapid City	South Dakota
United States	Eastside Research Associates	Redmond	Washington
United States	Northern Nevada Endocrinology	Reno	Nevada
United States	Renown South Meadows Medical Center	Reno	Nevada
United States	Elite Clinical Trials	Rexburg	Idaho
United States	SKY Clinical Research Network Group-Quinn	Ridgeland	Mississippi
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Texas Diabetes & Endocrinology, P.A.	Round Rock	Texas
United States	Chrysalis Clinical Research	Saint George	Utah
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
United States	Audie L Murphy VA Hospital	San Antonio	Texas
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Tekton Research - Fredericksburg Road	San Antonio	Texas
United States	VIP Trials	San Antonio	Texas
United States	LCGK Research	San Carlos	California
United States	Norcal Endocrinology & Internal Medicine	San Ramon	California
United States	Velocity Clinical Research, Coastal Heart Medical Group	Santa Ana	California
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Syed Research Consultants Llc	Sheffield	Alabama
United States	Carolina Research Center	Shelby	North Carolina
United States	Sherman Clinical Research	Sherman	Texas
United States	NorthShore University Health System	Skokie	Illinois
United States	Multicare Institute for Research and Innovation	Spokane	Washington
United States	Clinvest Research LLC	Springfield	Missouri
United States	Accellacare - Piedmont	Statesville	North Carolina
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Centricity Research Suffolk Primary Care	Suffolk	Virginia
United States	Clinical Research Institute of Arizona (CRI) - Sun City West	Sun City West	Arizona
United States	Universal Research Group	Tacoma	Washington
United States	Care Access - Tamarac	Tamarac	Florida
United States	Baycare Clinical Research	Tampa	Florida
United States	Care Access - Tampa	Tampa	Florida
United States	Precision Research Center	Tampa	Florida
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	Millennium Clinical Trials	Thousand Oaks	California
United States	Northwest Houston Heart Center	Tomball	Texas
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Cotton O'Neil Clinical Research Center - Central Office	Topeka	Kansas
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	Synexus Clinical Research US, Inc./Orange Grove Family Practice	Tucson	Arizona
United States	Tennessee Center for Clinical Trials	Tullahoma	Tennessee
United States	Central States Research	Tulsa	Oklahoma
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Kalo Clinical Research	West Valley City	Utah
United States	Encore Medical Research - Weston	Weston	Florida
United States	Tekton Research - Wichita	Wichita	Kansas
United States	Accellacare - Wilmington - 1917 Tradd Court	Wilmington	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	Conquest Research	Winter Park	Florida
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	Soma Clinical Trials	Wylie	Texas
United States	Tekton Research, Inc	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Czechia,  Germany,  Greece,  India,  Italy,  Korea, Republic of,  Mexico,  Puerto Rico,  Romania,  Slovakia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Baseline to End of the Study (Approximately 104 Weeks)
Secondary	Change from Baseline in Hemoglobin A1c (HbA1c)	Change from Baseline in HbA1c	Baseline, Week 52
Secondary	Change from Baseline in Fasting Serum Glucose	Change from Baseline in Fasting Serum Glucose	Baseline, Week 52
Secondary	Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile	Change from Baseline in Daily Average 7-point SMBG	Baseline, Week 52
Secondary	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)	Week 52
Secondary	Change from Baseline in Body Weight	Change from Baseline in Body Weight	Baseline, Week 52
Secondary	Percent Change from Baseline Body Weight	Percent Change from Baseline Body Weight	Week 52
Secondary	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.	Baseline, Week 52
Secondary	Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron	PK will be estimated based on the population PK model.	Baseline through Week 52

External Links

•   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)