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

March 18, 2024 updated by: Eli Lilly and Company

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

888

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230011
        • Recruiting
        • The Second People's Hospital of Hefei
        • Principal Investigator:
          • Jun Ye
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The Fourth Hospital of Harbin Medical University
        • Principal Investigator:
          • ZhiFeng Cheng
    • Henan
      • Nanyang, Henan, China, 473007
        • Recruiting
        • The First Affiliated Hospital of Nanyang Medical College
        • Principal Investigator:
          • Dexue Liu
      • Zhengzhou, Henan, China, 450014
        • Recruiting
        • The Second Affiliated Hospital Of Zhengzhou University
        • Principal Investigator:
          • Qingju Li
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Yibing Lu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Principal Investigator:
          • Jianhua Ma
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Bimin Shi
      • Zhenjiang, Jiangsu, China, 212000
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Guoyue Yuan
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Xiaolin Dong
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Principal Investigator:
          • Haoyong Yu
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Yushan Xu
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Principal Investigator:
          • Hong Zhu
  • Germany
      • Hamburg, Germany, 21109
        • Recruiting
        • Diabetes Zentrum Wilhelmsburg
        • Principal Investigator:
          • Peter Witzel
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Recruiting
        • CRS Clinical Research Services Mannheim
        • Principal Investigator:
          • Thomas Forst
    • Niedersachsen
      • Lingen, Niedersachsen, Germany, 49808
        • Recruiting
        • Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
        • Principal Investigator:
          • Andreas Staudenmeyer
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44869
        • Recruiting
        • Diabetes- und Stoffwechselpraxis Bochum
        • Principal Investigator:
          • Babette Lorra
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Recruiting
        • InnoDiab Forschung GmbH
        • Principal Investigator:
          • Helga Zeller
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • Recruiting
        • Medizentrum Essen Borbeck
        • Principal Investigator:
          • Axel Schaefer
      • Köln, Nordrhein-Westfalen, Germany, 51069
        • Recruiting
        • Zentrum fur klinische Forschung - Köln
        • Principal Investigator:
          • Bastian Kirsch
      • Münster, Nordrhein-Westfalen, Germany, 48145
        • Recruiting
        • Institut für Diabetesforschung GmbH Münster
        • Principal Investigator:
          • Ludger Rose
    • Rheinland-Pfalz
      • Ludwigshafen am Rhein, Rheinland-Pfalz, Germany, 67059
        • Not yet recruiting
        • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
        • Principal Investigator:
          • Hans-Peter Kempe
    • Saarland
      • Rehlingen, Saarland, Germany, 66780
        • Recruiting
        • Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer null Josef Wenzl
        • Principal Investigator:
          • Veronika Wenzl-Bauer
      • St.Ingbert, Saarland, Germany, 66386
        • Recruiting
        • Zentrum für klinische Studien
        • Principal Investigator:
          • Alexander Segner
    • Schleswig-Holstein
      • Oldenburg, Schleswig-Holstein, Germany, 23758
        • Recruiting
        • RED-Institut GmbH
        • Principal Investigator:
          • Thomas Schaum
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Not yet recruiting
        • Fundación Cardiovascular de Aguascalientes A.C.
        • Principal Investigator:
          • Edmundo Alfredo Bayram Llamas
      • Cuautitlán Izcalli, Mexico, 54700
        • Not yet recruiting
        • Estudios Clínicos Internacionales (ECI) - Cuautitlán Izcalli
        • Principal Investigator:
          • Maria Teresita Escalona
      • Durango, Mexico, 34000
        • Not yet recruiting
        • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
        • Principal Investigator:
          • José Roberto Lazcano Soto
      • Querétaro, Mexico, 76100
        • Not yet recruiting
        • PanAmerican Clinical Research - Querétaro - Avenida Antea
        • Principal Investigator:
          • Juan Villagordoa Mesa
    • Distrito Federal
      • Cuauhtémoc, Distrito Federal, Mexico, 06100
        • Not yet recruiting
        • Cryptex Investigación Clínica S.A. de C.V.
        • Principal Investigator:
          • MIGUEL ANGEL GOMEZ-SAMANO
      • Mexico City, Distrito Federal, Mexico, 14050
        • Not yet recruiting
        • ProcliniQ Investigación Clínica SA de CV
        • Principal Investigator:
          • Rafael Vidal Tamayo Ramirez
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42000
        • Not yet recruiting
        • Grupo Ollin Care
        • Principal Investigator:
          • Eduardo Zambrano Ruiz
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Not yet recruiting
        • Instituto Jalisciense de Investigacion en Diabetes y Obesidad
        • Principal Investigator:
          • Guillermo Gonzalez Galvez
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Not yet recruiting
        • Instituto de Diabetes, Obesidad y Nutricion
        • Principal Investigator:
          • Leobardo Sauque Reyna
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Not yet recruiting
        • Cardiolink Clin Trials
        • Principal Investigator:
          • Elías García
      • Monterrey, Nuevo León, Mexico, 64610
        • Not yet recruiting
        • Clínica García Flores SC
        • Principal Investigator:
          • Pedro Alberto Garcia
      • San Nicolas de los Garza, Nuevo León, Mexico, 66450
        • Not yet recruiting
        • Servicios Integrales Nova de Monterrey S.A. de C.V.
        • Principal Investigator:
          • Maria Elena Romero-Ibarguengoitia
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80230
        • Not yet recruiting
        • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
        • Principal Investigator:
          • Manuel Odin de los Rios Ibarra
    • Veracruz
      • Xalapa, Veracruz, Mexico, 91193
        • Not yet recruiting
        • Consultorio de Medicina Especilizada del Sector Privado
        • Principal Investigator:
          • Enrique Lopez Rosas
      • Xalapa, Veracruz, Mexico, 91193
        • Not yet recruiting
        • Hospital Angeles Xalapa
        • Principal Investigator:
          • Gustavo Mendez Machado
  • Poland
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 50-162
        • Recruiting
        • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
        • Principal Investigator:
          • Piotr Napora
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-231
        • Not yet recruiting
        • NZOZ Centrum Medyczne KERmed
        • Principal Investigator:
          • Tomasz Lugowski
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-078
        • Recruiting
        • Clinical Best Solutions
        • Principal Investigator:
          • Agata Smolen
      • Lublin, Lubelskie, Poland, 20-538
        • Recruiting
        • NZOZ Medica
        • Principal Investigator:
          • Ewa Skokowska
      • Lublin, Lubelskie, Poland, 20-044
        • Not yet recruiting
        • CenterMed Lublin NZOZ
        • Principal Investigator:
          • Ewa Szyprowska
    • Mazowieckie
      • Radom, Mazowieckie, Poland, 26-600
        • Recruiting
        • Centrum Medyczne "Diabetika"
        • Principal Investigator:
          • Dorota Mlodawska-Choluj
    • Małopolskie
      • Grojec, Małopolskie, Poland, 32-615
        • Not yet recruiting
        • Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"
        • Principal Investigator:
          • Jadwiga Czernek-Bruzgielewicz
      • Krakow, Małopolskie, Poland, 31-261
        • Recruiting
        • NZOZ Diab-Endo-Met
        • Principal Investigator:
          • Magdalena Kwiatkowska
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-351
        • Not yet recruiting
        • Osteo Medic sc A. Racewicz, J. Supronik
        • Principal Investigator:
          • Katarzyna Wasilewska
      • Bialystok, Podlaskie, Poland, 15-375
        • Not yet recruiting
        • Specderm Poznanska
        • Principal Investigator:
          • Katarzyna Siewko
    • Łódzkie
      • Lodz, Łódzkie, Poland, 90-338
        • Recruiting
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
        • Principal Investigator:
          • Malgorzata Jozefowska
    • Śląskie
      • Zabrze, Śląskie, Poland, 41-800
        • Not yet recruiting
        • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
        • Principal Investigator:
          • Janusz Gumprecht
  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Not yet recruiting
        • Kaohsiung Veterans General Hospital
        • Principal Investigator:
          • Chih-Hsun Chu
      • Kaohsiung, Taiwan, 807
        • Not yet recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Tsung-Hsien Lin
      • New Taipei, Taiwan, 24352
        • Not yet recruiting
        • Fu Jen Catholic University Hospital
        • Principal Investigator:
          • Dee Pei
      • Taichung, Taiwan, 407
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Principal Investigator:
          • Jun-Sing Wang
      • Tainan, Taiwan, 704
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • Horng-Yih Ou
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Chern-En Chiang
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Chih-Yuan Wang
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Not yet recruiting
        • Chang Gung Memorial Hospital at Kaohsiung
        • Principal Investigator:
          • Jung-Fu Chen
  • United States
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • Alliance Research Institute - Canoga Park
        • Principal Investigator:
          • Arash Matian
      • Long Beach, California, United States, 90815
        • Recruiting
        • Ark Clinical Research
        • Principal Investigator:
          • Apinya Bee Vutikullird
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Collaborative Neuroscience Research, LLC
        • Principal Investigator:
          • Steven H. Reynolds
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Wolverine Clinical Trials
        • Principal Investigator:
          • Behnam Khaleghi
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Recruiting
        • CMR of Greater New Haven
        • Principal Investigator:
          • Joseph Soufer
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Institute of Endocrinology Diabetes, Health & Hormone
        • Principal Investigator:
          • Shehzad Topiwala
    • Idaho
      • Rexburg, Idaho, United States, 83440
        • Recruiting
        • Elite Clinical Trials
        • Principal Investigator:
          • Brian P Beesley
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Recruiting
        • Accellacare - DuPage
        • Principal Investigator:
          • Yoko Momoyama
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Tandem Clinical Research
        • Principal Investigator:
          • Adil Fatakia
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • St. Vincent Healthcare
        • Principal Investigator:
          • Justen Rudolph
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Albuquerque Clinical Trials, Inc.
        • Principal Investigator:
          • Satkirin K Khalsa
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Accellacare - Winston-Salem
        • Principal Investigator:
          • Jonathan Wilson
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • Alliance for Multispecialty Research, LLC
        • Principal Investigator:
          • Lisa Connery
      • Tulsa, Oklahoma, United States, 74137
        • Recruiting
        • Essential Medical Research
        • Principal Investigator:
          • Jeffrey Chasteen
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Recruiting
        • Accellacare - Mt Pleasant
        • Principal Investigator:
          • Richard E. Mills
    • Tennessee
      • Jefferson City, Tennessee, United States, 37760
        • Recruiting
        • Accellacare, US Inc., d/b/a Accellacare of Knoxville
        • Principal Investigator:
          • John Kirby
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Dallas Diabetes Research Center
        • Principal Investigator:
          • Julio Rosenstock
      • Houston, Texas, United States, 77040
        • Recruiting
        • Juno Research
        • Principal Investigator:
          • Damaris Vega
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Consano Clinical Research, LLC
        • Principal Investigator:
          • Michelle Welch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 3
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Active Comparator: Dapagliflozin
Participants will receive dapagliflozin orally.
Drug: Dapagliflozin
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c: (HbA1c)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

October 27, 2025

Study Completion (Estimated)

October 27, 2025

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18566
  • J2A-MC-GZGV (Other Identifier: Eli Lilly and Company)
  • 2023-507206-13-00 (Other Identifier: EU Trial Number)
  • U1111-1296-1507 (Other Identifier: UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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