A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin

Type 2 Diabetes Clinical Trial

— ACHIEVE-2  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192108
• Other study ID #: 18566
• Secondary ID: J2A-MC-GZGV2023-
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2024
• Est. completion date: October 27, 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 888
• Est. completion date: October 27, 2025
• Est. primary completion date: October 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Orforglipron
Administered orally
• Dapagliflozin
Administered orally

Locations

Country	Name	City	State
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second People's Hospital of Hefei	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Nanyang Medical College	Nanyang	Henan
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Germany	Diabetes- und Stoffwechselpraxis Bochum	Bochum	Nordrhein-Westfalen
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	Medizentrum Essen Borbeck	Essen	Nordrhein-Westfalen
Germany	Diabetes Zentrum Wilhelmsburg	Hamburg
Germany	Zentrum fur klinische Forschung - Köln	Köln	Nordrhein-Westfalen
Germany	Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz	Lingen	Niedersachsen
Germany	Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz	Ludwigshafen am Rhein	Rheinland-Pfalz
Germany	CRS Clinical Research Services Mannheim	Mannheim	Baden-Württemberg
Germany	Institut für Diabetesforschung GmbH Münster	Münster	Nordrhein-Westfalen
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer null Josef Wenzl	Rehlingen	Saarland
Germany	Zentrum für klinische Studien	St.Ingbert	Saarland
Mexico	Fundación Cardiovascular de Aguascalientes A.C.	Aguascalientes
Mexico	Cryptex Investigación Clínica S.A. de C.V.	Cuauhtémoc	Distrito Federal
Mexico	Estudios Clínicos Internacionales (ECI) - Cuautitlán Izcalli	Cuautitlán Izcalli
Mexico	Instituto de Diabetes, Obesidad y Nutricion	Cuernavaca	Morelos
Mexico	Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.	Culiacan	Sinaloa
Mexico	Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia	Durango
Mexico	Instituto Jalisciense de Investigacion en Diabetes y Obesidad	Guadalajara	Jalisco
Mexico	Invecordis S.C.	Hacienda De Las Palmas	México
Mexico	ProcliniQ Investigación Clínica SA de CV	Mexico City	Distrito Federal
Mexico	Cardiolink Clin Trials	Monterrey	Nuevo León
Mexico	Clínica García Flores SC	Monterrey	Nuevo León
Mexico	Grupo Ollin Care	Pachuca	Hidalgo
Mexico	PanAmerican Clinical Research - Querétaro - Avenida Antea	Querétaro
Mexico	Servicios Integrales Nova de Monterrey S.A. de C.V.	San Nicolas de los Garza	Nuevo León
Mexico	Consultorio de Medicina Especilizada del Sector Privado	Xalapa	Veracruz
Mexico	Hospital Angeles Xalapa	Xalapa	Veracruz
Poland	Osteo Medic sc A. Racewicz, J. Supronik	Bialystok	Podlaskie
Poland	Specderm Poznanska	Bialystok	Podlaskie
Poland	NZOZ Centrum Medyczne KERmed	Bydgoszcz	Kujawsko-pomorskie
Poland	Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET	Krakow	Malopolskie
Poland	Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz	Lódzkie
Poland	CenterMed Lublin NZOZ	Lublin	Lubelskie
Poland	Clinical Best Solutions	Lublin	Lubelskie
Poland	NZOZ Medica	Lublin	Lubelskie
Poland	Centrum Medyczne "Diabetika"	Radom	Mazowieckie
Poland	Centrum Badan Klinicznych Piotr Napora lekarze sp.p.	Wroclaw	Dolnoslaskie
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1 SUM	Zabrze	Slaskie
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	Fu Jen Catholic University Hospital	New Taipei
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	St. Vincent Healthcare	Billings	Montana
United States	Alliance Research Institute - Canoga Park	Canoga Park	California
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	CMR of Greater New Haven	Hamden	Connecticut
United States	Juno Research	Houston	Texas
United States	Accellacare, US Inc., d/b/a Accellacare of Knoxville	Jefferson City	Tennessee
United States	Accellacare - DuPage	Lombard	Illinois
United States	Ark Clinical Research	Long Beach	California
United States	Collaborative Neuroscience Research, LLC	Los Alamitos	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Accellacare - Mt Pleasant	Mount Pleasant	South Carolina
United States	Intend Research, LLC	Norman	Oklahoma
United States	Elite Clinical Trials	Rexburg	Idaho
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Institute of Endocrinology Diabetes, Health & Hormone	Stockbridge	Georgia
United States	Essential Medical Research	Tulsa	Oklahoma
United States	Wolverine Clinical Trials	Tustin	California
United States	Accellacare - Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  China,  Germany,  Mexico,  Poland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c: (HbA1c)		Baseline, Week 40
Secondary	Change from Baseline in HbA1c		Baseline, Week 40
Secondary	Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol))		Week 40
Secondary	Percentage of Participants Who Achieved HbA1c =6.5% (48 mmol/mol)		Week 40
Secondary	Percentage Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol		Baseline, Week 40
Secondary	Percentage Change from Baseline in Triglycerides		Baseline, Week 40
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 40
Secondary	Change from Baseline in Fasting Serum Glucose		Baseline, Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =5% from Baseline		Baseline to Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =10% from baseline		Baseline to Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =15% from baseline		Baseline to Week 40
Secondary	Change from Baseline in Diastolic Blood Pressure (DBP)		Baseline, Week 40
Secondary	Percentage Change from Baseline in Total Cholesterol		Baseline, Week 40
Secondary	Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores		Baseline, Week 40
Secondary	Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores		Baseline, Week 40