A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin
ACHIEVE-2
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)
4 other identifiers
interventional
962
6 countries
74
Brief Summary
The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 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 Jan 2024
74 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
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedStudy Start
First participant enrolled
January 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2025
CompletedOctober 20, 2025
October 1, 2025
1.7 years
December 21, 2023
October 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c: (HbA1c)
Baseline, Week 40
Secondary Outcomes (16)
Change from Baseline in HbA1c
Baseline, Week 40
Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol))
Week 40
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
Week 40
Percentage Change from Baseline in Body Weight
Baseline, Week 40
Change from Baseline in Body Weight
Baseline, Week 40
- +11 more secondary outcomes
Study Arms (4)
Orforglipron Dose 1
EXPERIMENTALParticipants will receive orforglipron orally.
Orforglipron Dose 2
EXPERIMENTALParticipants will receive orforglipron orally.
Orforglipron Dose 3
EXPERIMENTALParticipants will receive orforglipron orally.
Dapagliflozin
ACTIVE COMPARATORParticipants will receive dapagliflozin orally.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- Have a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
- Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
- Have been on stable diabetes treatment with metformin ≥1500 milligram per day (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.
- Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.
You may not qualify if:
- Have Type 1 Diabetes (T1D)
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have an estimated glomerular filtration rate (eGFR) \<45 milliliter per minute (mL/min)/1.73 square meter (m2)
- Have acute or chronic hepatitis
- Have had chronic or acute pancreatitis any time.
- Have been treated with any antihyperglycemic medication (other than metformin) within the 90 days prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Alliance Research Institute - Canoga Park
Canoga Park, California, 91304, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720, United States
Wolverine Clinical Trials
Santa Ana, California, 92706, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517, United States
Institute of Endocrinology Diabetes, Health & Hormone
Stockbridge, Georgia, 30281, United States
Elite Clinical Trials
Rexburg, Idaho, 83440, United States
Accellacare - DuPage
Lombard, Illinois, 60148, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
St. Vincent Healthcare
Billings, Montana, 59101, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069, United States
Essential Medical Research
Tulsa, Oklahoma, 74137, United States
Accellacare - Mt Pleasant
Mt. Pleasant, South Carolina, 29464, United States
Accellacare, US Inc., d/b/a Accellacare of Knoxville
Jefferson City, Tennessee, 37760, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77040, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
The Second People's Hospital of Hefei
Hefei, Anhui, 230011, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007, 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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
CRS Clinical Research Services Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
Lingen, Lower Saxony, 49808, Germany
Diabetes- und Stoffwechselpraxis Bochum
Bochum, North Rhine-Westphalia, 44869, Germany
Zentrum fur klinische Forschung - Köln
Cologne, North Rhine-Westphalia, 51069, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136, Germany
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, 45355, Germany
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, 48145, Germany
Praxis Dr. Veronika Wenzl-Bauer
Rehlingen, Saarland, 66780, Germany
Zentrum für klinische Studien
Saint Ingbert, Saarland, 66386, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109, Germany
Grupo Ollin Care
Pachuca, Hidalgo, 42000, Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, 44600, Mexico
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad de México, Mexico City, 06100, Mexico
ProcliniQ Investigación Clínica SA de CV
Mexico City, Mexico City, 14050, Mexico
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, 62250, Mexico
Cardiolink Clin Trials
Monterrey, Nuevo León, 64060, Mexico
Clínica García Flores SC
Monterrey, Nuevo León, 64610, Mexico
Servicios Integrales Nova de Monterrey S.A. de C.V.
San Nicolás de los Garza, Nuevo León, 66450, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Sinaloa, 80230, Mexico
Consultorio de Medicina Especilizada del Sector Privado
Xalapa, Veracruz, 91193, Mexico
Hospital Angeles Xalapa
Xalapa, Veracruz, 91193, Mexico
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes, 20230, Mexico
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango, 34000, Mexico
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231, Poland
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261, Poland
Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
Wroclaw, Lower Silesian Voivodeship, 50-162, Poland
Clinical Best Solutions
Lublin, Lublin Voivodeship, 20-011, Poland
CenterMed Lublin NZOZ
Lublin, Lublin Voivodeship, 20-044, Poland
Ekamed
Lublin, Lublin Voivodeship, 20-718, Poland
Centrum Medyczne "Diabetika"
Radom, Masovian Voivodeship, 26-600, Poland
Zdrowie Osteo-Medic
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Specderm Poznanska
Bialystok, Podlaskie Voivodeship, 15-375, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, Silesian Voivodeship, 41-800, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship, 90-338, Poland
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Fu Jen Catholic University Hospital
New Taipei City, 24352, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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
December 21, 2023
First Posted
January 5, 2024
Study Start
January 10, 2024
Primary Completion
September 26, 2025
Study Completion
September 26, 2025
Last Updated
October 20, 2025
Record last verified: 2025-10
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 participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.