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

October 16, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
962

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • The Second People's Hospital of Hefei
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Nanyang, Henan, China, 473007
        • The First Affiliated Hospital of Nanyang Medical College
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Sixth People's Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Germany
      • Hamburg, Germany, 21109
        • Diabetes Zentrum Wilhelmsburg
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • CRS Clinical Research Services Mannheim
    • Lower Saxony
      • Lingen, Lower Saxony, Germany, 49808
        • Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44869
        • Diabetes- und Stoffwechselpraxis Bochum
      • Cologne, North Rhine-Westphalia, Germany, 51069
        • Zentrum fur klinische Forschung - Köln
      • Essen, North Rhine-Westphalia, Germany, 45355
        • Medizentrum Essen Borbeck
      • Essen, North Rhine-Westphalia, Germany, 45136
        • InnoDiab Forschung GmbH
      • Münster, North Rhine-Westphalia, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster
    • Saarland
      • Rehlingen, Saarland, Germany, 66780
        • Praxis Dr. Veronika Wenzl-Bauer
      • Saint Ingbert, Saarland, Germany, 66386
        • Zentrum für klinische Studien
    • Schleswig-Holstein
      • Oldenburg in Holstein, Schleswig-Holstein, Germany, 23758
        • Red-Institut GmbH
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Fundación Cardiovascular de Aguascalientes A.C.
      • Durango, Mexico, 34000
        • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42000
        • Grupo Ollin Care
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Instituto Jalisciense de Investigacion en Diabetes y Obesidad
    • Mexico City
      • Cuauhtémoc, Ciudad de México, Mexico City, Mexico, 06100
        • Cryptex Investigación Clínica S.A. de C.V.
      • Mexico City, Mexico City, Mexico, 14050
        • ProcliniQ Investigación Clínica SA de CV
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Instituto de Diabetes, Obesidad y Nutricion
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64610
        • Clínica García Flores SC
      • Monterrey, Nuevo León, Mexico, 64060
        • Cardiolink Clin Trials
      • San Nicolás de los Garza, Nuevo León, Mexico, 66450
        • Servicios Integrales Nova de Monterrey S.A. de C.V.
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
    • Veracruz
      • Xalapa, Veracruz, Mexico, 91193
        • Hospital Angeles Xalapa
      • Xalapa, Veracruz, Mexico, 91193
        • Consultorio de Medicina Especilizada del Sector Privado
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-231
        • NZOZ Centrum Medyczne KERmed
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-162
        • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-011
        • Clinical Best Solutions
      • Lublin, Lublin Voivodeship, Poland, 20-044
        • CenterMed Lublin NZOZ
      • Lublin, Lublin Voivodeship, Poland, 20-718
        • Ekamed
    • Masovian Voivodeship
      • Radom, Masovian Voivodeship, Poland, 26-600
        • Centrum Medyczne "Diabetika"
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Zdrowie Osteo-Medic
      • Bialystok, Podlaskie Voivodeship, Poland, 15-375
        • Specderm Poznanska
    • Silesian Voivodeship
      • Zabrze, Silesian Voivodeship, Poland, 41-800
        • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-338
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 24352
        • Fu Jen Catholic University Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Tainan City, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung
  • United States
    • California
      • Canoga Park, California, United States, 91304
        • Alliance Research Institute - Canoga Park
      • Long Beach, California, United States, 90815
        • ARK Clinical Research
      • Los Alamitos, California, United States, 90720
        • Collaborative Neuroscience Research, LLC
      • Santa Ana, California, United States, 92706
        • Wolverine Clinical Trials
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • CMR of Greater New Haven, LLC
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Institute of Endocrinology Diabetes, Health & Hormone
    • Idaho
      • Rexburg, Idaho, United States, 83440
        • Elite Clinical Trials
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Accellacare - DuPage
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
    • Montana
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Accellacare - Winston-Salem
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research, LLC
      • Tulsa, Oklahoma, United States, 74137
        • Essential Medical Research
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Accellacare - Mt Pleasant
    • Tennessee
      • Jefferson City, Tennessee, United States, 37760
        • Accellacare, US Inc., d/b/a Accellacare of Knoxville
    • Texas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Houston, Texas, United States, 77040
        • Juno Research
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c: (HbA1c)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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