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

NCT ID: NCT06192108

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

962 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-09-26

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orforglipron Dose 1

Participants will receive orforglipron orally.

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 2

Participants will receive orforglipron orally.

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 3

Participants will receive orforglipron orally.

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Dapagliflozin

Participants will receive dapagliflozin orally.

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

Administered orally

Interventions

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Orforglipron

Administered orally

Intervention Type DRUG

Dapagliflozin

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3502970

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Alliance Research Institute - Canoga Park

Canoga Park, California, United States

Site Status

Ark Clinical Research

Long Beach, California, United States

Site Status

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Site Status

Wolverine Clinical Trials

Santa Ana, California, United States

Site Status

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Site Status

Institute of Endocrinology Diabetes, Health & Hormone

Stockbridge, Georgia, United States

Site Status

Elite Clinical Trials

Rexburg, Idaho, United States

Site Status

Accellacare - DuPage

Lombard, Illinois, United States

Site Status

Tandem Clinical Research

Marrero, Louisiana, United States

Site Status

St. Vincent Healthcare

Billings, Montana, United States

Site Status

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, United States

Site Status

Accellacare - Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Site Status

Essential Medical Research

Tulsa, Oklahoma, United States

Site Status

Accellacare - Mt Pleasant

Mt. Pleasant, South Carolina, United States

Site Status

Accellacare, US Inc., d/b/a Accellacare of Knoxville

Jefferson City, Tennessee, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

Juno Research

Houston, Texas, United States

Site Status

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

The Second People's Hospital of Hefei

Hefei, Anhui, China

Site Status

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Site Status

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Site Status

Jinan Central Hospital

Jinan, Shandong, China

Site Status

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

CRS Clinical Research Services Mannheim

Mannheim, Baden-Wurttemberg, Germany

Site Status

Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz

Lingen, Lower Saxony, Germany

Site Status

Diabetes- und Stoffwechselpraxis Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status

Zentrum fur klinische Forschung - Köln

Cologne, North Rhine-Westphalia, Germany

Site Status

InnoDiab Forschung Gmbh

Essen, North Rhine-Westphalia, Germany

Site Status

Medizentrum Essen Borbeck

Essen, North Rhine-Westphalia, Germany

Site Status

Institut für Diabetesforschung GmbH Münster

Münster, North Rhine-Westphalia, Germany

Site Status

Praxis Dr. Veronika Wenzl-Bauer

Rehlingen, Saarland, Germany

Site Status

Zentrum für klinische Studien

Saint Ingbert, Saarland, Germany

Site Status

RED-Institut GmbH

Oldenburg in Holstein, Schleswig-Holstein, Germany

Site Status

Diabetes Zentrum Wilhelmsburg

Hamburg, , Germany

Site Status

Grupo Ollin Care

Pachuca, Hidalgo, Mexico

Site Status

Instituto Jalisciense de Investigacion en Diabetes y Obesidad

Guadalajara, Jalisco, Mexico

Site Status

Cryptex Investigación Clínica S.A. de C.V.

Cuauhtémoc, Ciudad de México, Mexico City, Mexico

Site Status

ProcliniQ Investigación Clínica SA de CV

Mexico City, Mexico City, Mexico

Site Status

Instituto de Diabetes, Obesidad y Nutricion

Cuernavaca, Morelos, Mexico

Site Status

Cardiolink Clin Trials

Monterrey, Nuevo León, Mexico

Site Status

Clínica García Flores SC

Monterrey, Nuevo León, Mexico

Site Status

Servicios Integrales Nova de Monterrey S.A. de C.V.

San Nicolás de los Garza, Nuevo León, Mexico

Site Status

Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

Culiacán, Sinaloa, Mexico

Site Status

Consultorio de Medicina Especilizada del Sector Privado

Xalapa, Veracruz, Mexico

Site Status

Hospital Angeles Xalapa

Xalapa, Veracruz, Mexico

Site Status

Fundación Cardiovascular de Aguascalientes A.C.

Aguascalientes, , Mexico

Site Status

Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

Durango, , Mexico

Site Status

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Centrum Badań Klinicznych Piotr Napora lekarze sp.p.

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Clinical Best Solutions

Lublin, Lublin Voivodeship, Poland

Site Status

CenterMed Lublin NZOZ

Lublin, Lublin Voivodeship, Poland

Site Status

Ekamed

Lublin, Lublin Voivodeship, Poland

Site Status

Centrum Medyczne "Diabetika"

Radom, Masovian Voivodeship, Poland

Site Status

Zdrowie Osteo-Medic

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Specderm Poznanska

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

Zabrze, Silesian Voivodeship, Poland

Site Status

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, Poland

Site Status

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Fu Jen Catholic University Hospital

New Taipei City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States China Germany Mexico Poland Taiwan

Related Links

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https://trials.lilly.com/en-US/trial/448175

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

Other Identifiers

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J2A-MC-GZGV

Identifier Type: OTHER

Identifier Source: secondary_id

2023-507206-13-00

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1296-1507

Identifier Type: OTHER

Identifier Source: secondary_id

18566

Identifier Type: -

Identifier Source: org_study_id

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