A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
NCT ID: NCT06109311
Last Updated: 2025-10-20
Study Results
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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COMPLETED
PHASE3
546 participants
INTERVENTIONAL
2023-11-10
2025-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Orforglipron Dose 1
Participants will receive orforglipron orally.
Orforglipron
Administered orally.
Orforglipron Dose 2
Participants will receive orforglipron orally.
Orforglipron
Administered orally.
Orforglipron Dose 3
Participants will receive orforglipron orally.
Orforglipron
Administered orally.
Placebo
Participants will receive placebo orally.
Placebo
Administered orally.
Interventions
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Orforglipron
Administered orally.
Placebo
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c ≥7.0% \[53 mmol/mol\] to ≤10.5% \[91 mmol/mol\]
* Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:
* insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
* insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
* metformin, or
* SGLT-2 inhibitor, or
* both metformin and SGLT-2 inhibitor.
* Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 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 kg/m\^2 at baseline.
Exclusion Criteria
* Have had any of the following cardiovascular conditions within 60 days prior to baseline.
* acute myocardial infarction
* cerebrovascular accident (stroke), or
* hospitalization for congestive heart failure.
* Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
* Have had chronic or acute pancreatitis any time.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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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MD First Research - Chandler
Chandler, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
SanRo Clinical Research Group
Bryant, Arkansas, United States
Velocity Clinical Research, Gardena
Gardena, California, United States
Loma Linda University Health System
Loma Linda, California, United States
Western University of Health Sciences
Pomona, California, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Care Access - Brandon
Brandon, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Orita Clinical Research
Decatur, Georgia, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
St. Luke's Humphreys Diabetes Center: Boise
Boise, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
The Research Group of Lexington
Lexington, Kentucky, United States
Clinvest Headlands Llc
Springfield, Missouri, United States
Richmond University Medical Center
Staten Island, New York, United States
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Tristar Clinical Investigations
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Lifedoc Research - Lenox Park Drive
Memphis, Tennessee, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
CEDOES
Vitória, Espírito Santo, Brazil
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, Brazil
Quanta Diagnóstico e Terapia
Curitiba, Paraná, Brazil
Insight Centro de Pesquisas
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, São Paulo, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
The Second People's Hospital of Hefei
Hefei, Anhui, China
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jinan Central Hospital
Jinan, Shandong, China
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, Japan
Hasegawa Medical Clinic
Chitose, Hokkaido, Japan
MinamiAkatsukaClinic
Mito, Ibaraki, Japan
Matoba Internal Medicine Clinic
Ebina, Kanagawa, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, Japan
Shiraiwa Medical Clinic
Kashihara, Osaka, Japan
The Institute of Medical Science, Asahi Life Foundation
Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, Japan
Tama Center Clinic Mirai
Tama, Tokyo, Japan
Jinnouchi Hospital
Kumamoto, , Japan
Kansai Electric Power Hospital
Osaka, , Japan
Abe Clinic
Ōita, , Japan
Centro de Endocrinologia y Nutricion
Caguas, , Puerto Rico
FDI Clinical Research
San Juan, , Puerto Rico
Diabdana
Oradea, Bihor County, Romania
C.M.D.T.A. Neomed
Brasov, Brașov County, Romania
Geea Medical Easy Diet
Bucharest, București, Romania
Centrul Medical NutriLife
Bucharest, București, Romania
Centrul Medical Endocrinologie si Diabet Dr. Paveliu
Bucharest, București, Romania
CMI DNBM Dr. Pop Lavinia
Baia Mare, Maramureş, Romania
SC Dentosim Queen SRL - Centrul Medical Diamed
Târgu Mureş, Mureș County, Romania
Milena Sante
Galați, , Romania
Diamed Obesity
Galați, , Romania
Clinica Korall
Satu Mare, , Romania
Countries
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Related Links
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A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor (ACHIEVE-5)
Other Identifiers
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J2A-MC-GZGW
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1294-2797
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507280-18-00
Identifier Type: OTHER
Identifier Source: secondary_id
18567
Identifier Type: -
Identifier Source: org_study_id
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