A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
ACHIEVE-3
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)
3 other identifiers
interventional
1,698
6 countries
131
Brief Summary
The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.
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 Sep 2023
Typical duration for phase_3 type-2-diabetes
131 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
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2025
CompletedSeptember 22, 2025
September 1, 2025
1.9 years
September 13, 2023
September 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 52
Secondary Outcomes (20)
Change from Baseline in HbA1c
Baseline, Week 52
Percentage of Participants Who Achieved HbA1c <7.0% 53 millimole/mole (mmol/mol)
Week 52
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
Week 52
Percentage Change from Baseline in Body Weight
Baseline, Week 52
Change from Baseline in Body Weight
Baseline, Week 52
- +15 more secondary outcomes
Study Arms (4)
Orforglipron Dose 1
EXPERIMENTALParticipants will receive orforglipron orally.
Orforglipron Dose 2
EXPERIMENTALParticipants will receive orforglipron orally.
Semaglutide Dose 1
ACTIVE COMPARATORParticipants will receive semaglutide orally.
Semaglutide Dose 2
ACTIVE COMPARATORParticipants will receive semaglutide orally.
Interventions
Eligibility Criteria
You may qualify if:
- Have Type 2 Diabetes
- 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
You may not qualify if:
- Have Type 1 Diabetes
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (131)
Absolute Clinical Research
Phoenix, Arizona, 85051, United States
San Fernando Valley Health Institute
Canoga Park, California, 91304, United States
Neighborhood Healthcare Institute of Health
Escondido, California, 92025, United States
Velocity Clinical Research, Gardena
Gardena, California, 90247, United States
Biopharma Informatic, LLC
Los Angeles, California, 90035, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Infinity Clinical Research - Norco
Norco, California, 92860, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
New West Physicians Clinical Research
Golden, Colorado, 80401, United States
Connecticut Clinical Research - Cromwell
Cromwell, Connecticut, 06416, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765, United States
South Florida Clinical Research Institute
Margate, Florida, 33063, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
West Orange Endocrinology
Ocoee, Florida, 34761, United States
Latin Clinical Trial Center Florida
Tamarac, Florida, 33321, United States
Clinical Research of West Florida
Tampa, Florida, 33606, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Family First Medical Center
Idaho Falls, Idaho, 83404, United States
American Health Network of Indiana, LLC - Greenfield
Greenfield, Indiana, 46140, United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Tekton Research, Inc
Wichita, Kansas, 67218, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Revival Research Institute, LLC
Dearborn, Michigan, 48126, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Wr-Crcn, Llc
Las Vegas, Nevada, 89106, United States
Premier Research
Trenton, New Jersey, 08611, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203, United States
Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York, 11215, United States
Great Lakes Medical Research, LLC
Westfield, New York, 14787, United States
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
Accellacare - Piedmont
Statesville, North Carolina, 28625, United States
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, 27104, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
Tekton Research, Inc
Moore, Oklahoma, 73160, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, 15236, United States
The Research Center of The Upstate
Greenville, South Carolina, 29607, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119, United States
Velocity Clinical Research, Austin
Austin, Texas, 78759, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, 76132, United States
Juno Research
Houston, Texas, 77040, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
Clear Brook Medical Associates
Houston, Texas, 77089, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Synexus Clinical Research US, Inc.
Salt Lake City, Utah, 84106, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina
CIMeL
Lanús, Buenos Aires, B1824KAJ, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
Policlinica Red OMIP
Mar del Plata, Buenos Aires, 7600, Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., 1405, Argentina
CIPREC
Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Instituto Centenario
CABA, Buenos Aires F.D., 1204, Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa Province, 6300, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, 2000, Argentina
Instituto de Especialidades de la Salud Rosario
Rosario, Santa Fe Province, 2000, Argentina
Instituto Médico Catamarca IMEC
Rosario, Santa Fe Province, 2000, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, 2000, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ, Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, 5000, Argentina
Instituto Médico DAMIC
Córdoba, 5003DCE, Argentina
Sanatorio Norte
Santiago del Estero, 4200, Argentina
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, 101200, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014, China
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, 528399, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003, China
Nanyang First People's Hospital
Nanyang, Henan, 473014, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030, China
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, 201200, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, 116099, Japan
Manda Memorial Hospital
Sapporo, Hokkaido, 060-0062, Japan
Nakamoto Internal Medicine Clinic
Mito, Ibaraki, 310-0826, Japan
Nakakinen clinic
Naka, Ibaraki, 311-0113, Japan
Ohishi Internal Medicine Clinic
Tsuchiura, Ibaraki, 300-0835, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056, Japan
Shiraiwa Medical Clinic
Kashihara, Osaka, 582-0005, Japan
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, 143-0015, Japan
Gifu University Hospital
Gifu, 501-1112, Japan
Centro de Investigacion Medica Integral
Guadalajara, Jalisco, 44160, Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, 44600, Mexico
CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C
Guadalajara, Jalisco, 44670, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44670, Mexico
Virgen Cardiovascular Research SC
Guadalajara, Jalisco, 44670, Mexico
Centro de Investigacion Medica de Occidente, S.C.
Zapopan, Jalisco, 44260, Mexico
Caimed Investigacion En Salud S.A. de C.V.
Mexico City, Mexico City, 06760, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650, Mexico
Cardiolink Clin Trials
Monterrey, Nuevo León, 64060, Mexico
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, 64460, Mexico
Clínica García Flores SC
Monterrey, Nuevo León, 64610, Mexico
Eukarya PharmaSite
Monterrey, Nuevo León, 64718, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
Centro de investigación y control metabólico
San Nicolás de los Garza, Nuevo León, 66465, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Sinaloa, 80230, Mexico
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango, 34000, Mexico
Isis Clinical Research Center
Guaynabo, PR, 00968, Puerto Rico
Mgcendo Llc
San Juan, PR, 00921, Puerto Rico
Research and Cardiovascular Corp.
Ponce, 00717, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
September 13, 2023
First Posted
September 21, 2023
Study Start
September 22, 2023
Primary Completion
August 22, 2025
Study Completion
August 22, 2025
Last Updated
September 22, 2025
Record last verified: 2025-09
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.