A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
NCT ID: NCT06045221
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1698 participants
INTERVENTIONAL
2023-09-22
2025-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orforglipron Dose 1
Participants will receive orforglipron orally.
Orforglipron
Administered orally
Orforglipron Dose 2
Participants will receive orforglipron orally.
Orforglipron
Administered orally
Semaglutide Dose 1
Participants will receive semaglutide orally.
Semaglutide
Administered orally
Semaglutide Dose 2
Participants will receive semaglutide orally.
Semaglutide
Administered orally
Interventions
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Orforglipron
Administered orally
Semaglutide
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening.
* Have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization.
* Are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment
Exclusion Criteria
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
* Have a New York Heart Association functional classification IV congestive heart failure.
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
* Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Absolute Clinical Research
Phoenix, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
Velocity Clinical Research, Gardena
Gardena, California, United States
Biopharma Informatic, LLC
Los Angeles, California, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Infinity Clinical Research - Norco
Norco, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, United States
Encompass Clinical Research
Spring Valley, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
New West Physicians Clinical Research
Golden, Colorado, United States
Connecticut Clinical Research - Cromwell
Cromwell, Connecticut, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
South Florida Clinical Research Institute
Margate, Florida, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Latin Clinical Trial Center Florida
Tamarac, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Family First Medical Center
Idaho Falls, Idaho, United States
American Health Network of Indiana, LLC - Greenfield
Greenfield, Indiana, United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Tekton Research, Inc
Wichita, Kansas, United States
DelRicht Research
New Orleans, Louisiana, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Revival Research Institute, LLC
Dearborn, Michigan, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Logan Health Research
Kalispell, Montana, United States
Wr-Crcn, Llc
Las Vegas, Nevada, United States
Premier Research
Trenton, New Jersey, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, United States
Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York, United States
Great Lakes Medical Research, LLC
Westfield, New York, United States
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, United States
Lucas Research, Inc
Morehead City, North Carolina, United States
Accellacare - Piedmont
Statesville, North Carolina, United States
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, United States
Aventiv Research Inc
Columbus, Ohio, United States
Tekton Research, Inc
Moore, Oklahoma, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, United States
The Research Center of The Upstate
Greenville, South Carolina, United States
New Phase Research and Development
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
Velocity Clinical Research, Austin
Austin, Texas, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, United States
Juno Research
Houston, Texas, United States
Endocrine Ips, Pllc
Houston, Texas, United States
Clear Brook Medical Associates
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Synexus Clinical Research US, Inc.
Salt Lake City, Utah, United States
Eastside Research Associates
Redmond, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
CIMeL
Lanús, Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Policlinica Red OMIP
Mar del Plata, Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., Argentina
CIPREC
Buenos Aires, Buenos Aires F.D., Argentina
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Centenario
CABA, Buenos Aires F.D., Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa Province, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, Argentina
Instituto de Especialidades de la Salud Rosario
Rosario, Santa Fe Province, Argentina
Instituto Médico Catamarca IMEC
Rosario, Santa Fe Province, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, , Argentina
Instituto Médico DAMIC
Córdoba, , Argentina
Sanatorio Norte
Santiago del Estero, , Argentina
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, Japan
Manda Memorial Hospital
Sapporo, Hokkaido, Japan
Nakamoto Internal Medicine Clinic
Mito, Ibaraki, Japan
Nakakinen clinic
Naka, Ibaraki, Japan
Ohishi Internal Medicine Clinic
Tsuchiura, Ibaraki, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, Japan
Shiraiwa Medical Clinic
Kashihara, Osaka, Japan
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, Japan
Gifu University Hospital
Gifu, , Japan
Centro de Investigacion Medica Integral
Guadalajara, Jalisco, Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, Mexico
CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C
Guadalajara, Jalisco, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, Mexico
Virgen Cardiovascular Research SC
Guadalajara, Jalisco, Mexico
Centro de Investigacion Medica de Occidente, S.C.
Zapopan, Jalisco, Mexico
Caimed Investigacion En Salud S.A. de C.V.
Mexico City, Mexico City, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, Mexico
Cardiolink Clin Trials
Monterrey, Nuevo León, Mexico
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, Mexico
Clínica García Flores SC
Monterrey, Nuevo León, Mexico
Eukarya PharmaSite
Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Centro de investigación y control metabólico
San Nicolás de los Garza, Nuevo León, 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
Isis Clinical Research Center
Guaynabo, PR, Puerto Rico
Mgcendo Llc
San Juan, PR, Puerto Rico
Research and Cardiovascular Corp.
Ponce, , Puerto Rico
Latin Clinical Trial Center
San Juan, , Puerto Rico
Countries
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Related Links
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A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin (ACHIEVE-3)
Other Identifiers
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J2A-MC-GZGU
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1290-6014
Identifier Type: OTHER
Identifier Source: secondary_id
18565
Identifier Type: -
Identifier Source: org_study_id
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