Type 2 DiabetesPhase 3ACHIEVE-3NCT06045221
A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
A Phase 3 study testing Orforglipron and Semaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 131 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Orforglipron and Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,698 participants
- Where
- 131 sitesin 6 countries
- Study dates
- 22 Sep 2023to 22 Aug 2025
- Phase
- Phase 3
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 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
Who cannot join
- 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.
Trial locations and contacts
131 sites in 6 countries.
131 sites in 6 countries
United States64 sites
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203
Velocity Clinical Research, Austin
Austin, Texas, 78759
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009
Northwest Clinical Trials
Boise, Idaho, 83704
Joslin Diabetes Center
Boston, Massachusetts, 02215
Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York, 11215
San Fernando Valley Health Institute
Canoga Park, California, 91304
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
Aventiv Research Inc
Columbus, Ohio, 43213
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330
Connecticut Clinical Research - Cromwell
Cromwell, Connecticut, 06416
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Revival Research Institute, LLC
Dearborn, Michigan, 48126
Neighborhood Healthcare Institute of Health
Escondido, California, 92025
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, 76132
Velocity Clinical Research, Gardena
Gardena, California, 90247
New West Physicians Clinical Research
Golden, Colorado, 80401
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
Juno Research
Houston, Texas, 77040
Endocrine Ips, Pllc
Houston, Texas, 77079
Clear Brook Medical Associates
Houston, Texas, 77089
Family First Medical Center
Idaho Falls, Idaho, 83404
Logan Health Research
Kalispell, Montana, 59901
Kansas City Research Institute
Kansas City, Missouri, 64131
New Phase Research and Development
Knoxville, Tennessee, 37909
Wr-Crcn, Llc
Las Vegas, Nevada, 89106
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046
Biopharma Informatic, LLC
Los Angeles, California, 90035
Velocity Clinical Research, Westlake
Los Angeles, California, 90057
South Florida Clinical Research Institute
Margate, Florida, 33063
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119
Southern Endocrinology Associates
Mesquite, Texas, 75149
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
Tekton Research, Inc
Moore, Oklahoma, 73160
Lucas Research, Inc
Morehead City, North Carolina, 28557
DelRicht Research
New Orleans, Louisiana, 70115
Infinity Clinical Research - Norco
Norco, California, 92860
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Valley Clinical Trials, Inc.
Northridge, California, 91325
West Orange Endocrinology
Ocoee, Florida, 34761
Absolute Clinical Research
Phoenix, Arizona, 85051
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, 15236
Eastside Research Associates
Redmond, Washington, 98052
Rainier Clinical Research Center
Renton, Washington, 98057
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
Synexus Clinical Research US, Inc.
Salt Lake City, Utah, 84106
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583
Encompass Clinical Research
Spring Valley, California, 91978
Accellacare - Piedmont
Statesville, North Carolina, 28625
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Latin Clinical Trial Center Florida
Tamarac, Florida, 33321
Clinical Research of West Florida
Tampa, Florida, 33606
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
Premier Research
Trenton, New Jersey, 08611
University Clinical Investigators, Inc.
Tustin, California, 92780
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383
Texas Valley Clinical Research
Weslaco, Texas, 78596
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Great Lakes Medical Research, LLC
Westfield, New York, 14787
Tekton Research, Inc
Wichita, Kansas, 67218
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, 27104
North Georgia Clinical Research
Woodstock, Georgia, 30189
China21 sites
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, 101200
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, 528399
Zhejiang Hospital
Hangzhou, Zhejiang, 310013
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Jinan Central Hospital
Jinan, Shandong, 250013
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003
Nanjing First Hospital
Nanjing, Jiangsu, 210006
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Nanyang First People's Hospital
Nanyang, Henan, 473014
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, 201200
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000
Argentina17 sites
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., 1405
CIPREC
Buenos Aires, Buenos Aires F.D., C1061AAS
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC
Instituto Centenario
CABA, Buenos Aires F.D., 1204
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056
Instituto de Investigaciones Clínicas Córdoba
Córdoba, 5000
Instituto Médico DAMIC
Córdoba, 5003DCE
CIMeL
Lanus, Buenos Aires, B1824KAJ
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, 7600
Policlinica Red OMIP
Mar del Plata, Buenos Aires, 7600
INECO Neurociencias Oroño
Rosario, Santa Fe Province, 2000
Instituto de Especialidades de la Salud Rosario
Rosario, Santa Fe Province, 2000
Instituto Médico Catamarca IMEC
Rosario, Santa Fe Province, 2000
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, 2000
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa Province, 6300
Sanatorio Norte
Santiago del Estero, 4200
Mexico16 sites
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Sinaloa, 80230
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango, 34000
Centro de Investigacion Medica Integral
Guadalajara, Jalisco, 44160
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, 44600
CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C
Guadalajara, Jalisco, 44670
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44670
Virgen Cardiovascular Research SC
Guadalajara, Jalisco, 44670
Caimed Investigacion En Salud S.A. de C.V.
Mexico City, Mexico City, 06760
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650
Cardiolink Clin Trials
Monterrey, Nuevo León, 64060
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, 64460
Clínica García Flores SC
Monterrey, Nuevo León, 64610
Eukarya PharmaSite
Monterrey, Nuevo León, 64718
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Centro de investigación y control metabólico
San Nicolás de los Garza, Nuevo León, 66465
Centro de Investigacion Medica de Occidente, S.C.
Zapopan, Jalisco, 44260
Japan9 sites
Gifu University Hospital
Gifu, 501-1112
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056
Shiraiwa Medical Clinic
Kashihara, Osaka, 582-0005
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, 116099
Nakamoto Internal Medicine Clinic
Mito, Ibaraki, 310-0826
Nakakinen clinic
Naka, Ibaraki, 311-0113
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, 143-0015
Manda Memorial Hospital
Sapporo, Hokkaido, 060-0062
Ohishi Internal Medicine Clinic
Tsuchiura, Ibaraki, 300-0835
Puerto Rico4 sites
Isis Clinical Research Center
Guaynabo, PR, 00968
Research and Cardiovascular Corp.
Ponce, 00717
Mgcendo Llc
San Juan, PR, 00921
Latin Clinical Trial Center
San Juan, 00909
About this study
Official title: 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)
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Orforglipron, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
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
SemaglutideDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 12 mg Orforglipron | Experimental | Participants initiated treatment with a 1 mg once-daily oral dose of orforglipron and increased the dose every 4 weeks until the targeted dose of 12 mg once-daily was reached, after which this dose was to be continued for the remainder of the 52-week treatment period. Receives: Drug: Orforglipron |
| 36 mg Orforglipron | Experimental | Participants initiated treatment with a 1 mg once-daily oral dose of orforglipron and increased the dose every 4 weeks until the targeted dose of 36 mg once-daily was reached, after which this dose was to be continued for the remainder of the 52-week treatment period. Receives: Drug: Orforglipron |
| 7 mg Semaglutide | Active comparator | Participants initiated treatment with a 3 mg once-daily oral dose of semaglutide and increased the dose every 4 weeks until the targeted dose of 7 mg once-daily was reached, after which this dose was to be continued for the remainder of the 52-week treatment period. Receives: Drug: Semaglutide |
| 14 mg Semaglutide | Active comparator | Participants initiated treatment with a 3 mg once-daily oral dose of semaglutide and increased the dose every 4 weeks until the targeted dose of 14 mg once-daily was reached, after which this dose was to be continued for the remainder of the 52-week treatment period. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c) [Non-inferiority of 36 mg Orforglipron Versus 14 mg Semaglutide and 12 mg Orforglipron Versus 7 mg Semaglutide]
- HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
- LS mean was analysed by mixed model repeated measures (MMRM) model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Secondary outcomes (20)
Change From Baseline in Hemoglobin A1c (HbA1c) [Non-inferiority of 12 mg Orforglipron Versus 14 mg Semaglutide, Superiority of 12 mg and 36 mg Orforglipron Versus 7 mg and 14 mg Semaglutide]
- HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
- LS mean was analysed by mixed model repeated measures (MMRM) model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percentage of Participants Who Achieved HbA1c <7.0% [53 Millimoles/Mole (mmol/Mol)]
The reported values represent model-based group mean percentages estimated from a logistic regression model using imputed data, with estimates combined across multiple imputations using Rubin's rule. Logistic regression model variables: Country + Treatment*Baseline + Treatment*Strata (defined by baseline HbA1c level [<=8.0%, >8.0%]).
Measured: Week 52
Percentage of Participants Who Achieved HbA1c <=6.5% (48 mmol/Mol)
The reported values represent model-based group mean percentages estimated from a logistic regression model using imputed data, with estimates combined across multiple imputations using Rubin's rule. Logistic regression model variables: Country + Treatment*Baseline + Treatment*Strata (defined by baseline HbA1c level [<=8.0%, >8.0%]).
Measured: Week 52
Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/Mol)
The reported values represent model-based group mean percentages estimated from a logistic regression model using imputed data, with estimates combined across multiple imputations using Rubin's rule. Logistic regression model variables: Country + Treatment*Baseline + Treatment*Strata (defined by baseline HbA1c level [<=8.0%, >8.0%]).
Measured: Week 52
Percent Change From Baseline in Body Weight
LS mean was analysed by MMRM model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Change From Baseline in Body Weight
LS mean was analysed by MMRM model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Change From Baseline in Fasting Serum Glucose
LS mean was analysed by MMRM model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG)
The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS mean was analysed by MMRM model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percentage of Participants Who Achieved Weight Loss of >=5%
The reported values represent model-based group mean percentages estimated from a logistic regression model using imputed data, with estimates combined across multiple imputations using Rubin's rule. Logistic regression model variables: Country + Treatment*Baseline + Treatment*Strata (defined by baseline HbA1c level [<=8.0%, >8.0%]).
Measured: Week 52
Percentage of Participants Who Achieved Weight Loss of >=10%
The reported values represent model-based group mean percentages estimated from a logistic regression model using imputed data, with estimates combined across multiple imputations using Rubin's rule. Logistic regression model variables: Country + Treatment*Baseline + Treatment*Strata (defined by baseline HbA1c level [<=8.0%, >8.0%]).
Measured: Week 52
Percentage of Participants Who Achieved Weight Loss of >=15%
The reported values represent model-based group mean percentages estimated from a logistic regression model using imputed data, with estimates combined across multiple imputations using Rubin's rule. Logistic regression model variables: Country + Treatment*Baseline + Treatment*Strata (defined by baseline HbA1c level [<=8.0%, >8.0%]).
Measured: Week 52
Change From Baseline in Systolic Blood Pressure (SBP)
LS mean was analysed by MMRM model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Change From Baseline in Diastolic Blood Pressure (DBP)
LS mean was analysed by MMRM model with Country + Baseline*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percent Change From Baseline in Total Serum Cholesterol
LS mean was analysed by MMRM model with Country + log(Baseline)*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percent Change From Baseline in Serum Low Density Lipoprotein (LDL) Cholesterol
LS mean was analysed by MMRM model with Country + log(Baseline)*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percent Change From Baseline in Serum Non High Density Lipoprotein (Non-HDL) Cholesterol
LS mean was analysed by MMRM model with Country + log(Baseline)*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percent Change From Baseline in Serum Triglycerides
LS mean was analysed by MMRM model with Country + log(Baseline)*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percent Change From Baseline in Serum High Density Lipoprotein (HDL) Cholesterol
LS mean was analysed by MMRM model with Country + log(Baseline)*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Percent Change From Baseline in Serum Very Low Density Lipoprotein (VLDL) Cholesterol
LS mean was analysed by MMRM model with Country + log(Baseline)*Time*Treatment + Strata*Time*Treatment as variables. Strata is defined by joint levels of HbA1c level (<=8.0%, >8.0%).
Measured: Baseline, Week 52
Change From Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form (Physical Component and Mental Component Scores)
The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the physical component summary and mental component summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 Sep 2023
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045221
- Sponsor's protocol ID
- 18565
- Other IDs
- J2A-MC-GZGU, U1111-1290-6014
- Acronym
- ACHIEVE-3
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2023
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Rosenstock J, Yabe D, Cox D, Li J, Denning M, Wu WS, Liu R, Zhao Y; ACHIEVE-3 Investigators. Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial. Lancet. 2026 Mar 21;407(10534):1147-1160. doi: 10.1016/S0140-6736(26)00202-3. Epub 2026 Feb 26.
PubMed 41765029