A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
NCT ID: NCT05971940
Last Updated: 2025-04-23
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
559 participants
INTERVENTIONAL
2023-08-09
2025-04-03
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 ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
* Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
* Are of stable 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 a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have New York Heart Association functional classification IV congestive heart failure.
* Have acute or chronic pancreatitis
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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Syed Research Consultants Llc
Sheffield, Alabama, United States
Epic Medical Research - Surprise
Surprise, Arizona, United States
Quality of Life Medical & Research Center
Tucson, Arizona, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Ark Clinical Research
Long Beach, California, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Infinity Clinical Research - Norco
Norco, California, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Connecticut Clinical Research - Cromwell
Cromwell, Connecticut, United States
Invictus Clinical Research Group
Coconut Creek, Florida, United States
Hillcrest Medical Research
DeLand, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Family First Medical Center
Idaho Falls, Idaho, United States
American Health Network of Indiana, LLC - Muncie
Muncie, Indiana, United States
Tekton Research - Wichita
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States
Revival Research Institute
Dearborn, Michigan, United States
Billings Clinic
Billings, Montana, United States
Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York, United States
Central New York Clinical Research
Manlius, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Lucas Research - New Bern
New Bern, North Carolina, United States
Centricity Research Dublin Multispecialty
Dublin, Ohio, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
The Research Center of The Upstate
Greenville, South Carolina, United States
MDFirst Research, LLC
Lancaster, South Carolina, United States
The Jackson Clinic
Jackson, Tennessee, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Juno Research
Houston, Texas, United States
Endocrine Ips, Pllc
Houston, Texas, United States
Amir A Hassan, MD, PA
Houston, Texas, United States
Burke Internal Medicine and Research
Burke, Virginia, United States
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China
Luhe Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Nanyang First People's Hospital
Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jinan Central Hospital
Jinan, Shandong, China
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
GMERS Medical College and General Hospital
Vadodara, Gujarat, India
M S Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Medstar Speciality Hospital
Bangalore, Karnataka, India
BSES MG Hospital
Mumbai, Maharashtra, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, Maharashtra, India
Grant Medical Foundation - Ruby Hall Clinic
Pune, Maharashtra, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, India
Kumudini Devi Diabetes Research Center
Hyderabad, Telangana, India
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata, West Bengal, India
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, Japan
Steel Memorial Yahata Hospital
Kitakyushu, Fukuoka, Japan
Hasegawa Medical Clinic
Chitose, Hokkaido, Japan
MinamiAkatsukaClinic
Mito, Ibaraki, Japan
Iwamoto Clinic
Zentsujichó, Kagawa-ken, Japan
Hayashi Diabetes Internal Medicine Clinic
Chigasaki, Kanagawa, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, 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
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Morinaga Ueno Clinic
Kumamoto, , Japan
Abe Clinic
Ōita, , Japan
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
Guadalajara, Jalisco, Mexico
Centro de Investigacion Medica Integral
Guadalajara, Jalisco, Mexico
Salud Cardiovascular
Guadalajara, Jalisco, Mexico
Centro de Investigacion Medica de Occidente, S.C.
Zapopan, Jalisco, Mexico
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
Chihuahua City, , Mexico
PanAmerican Clinical Research - Querétaro - Avenida Antea
Querétaro, , Mexico
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz, , Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
Puerto Rico Health Institute
Dorado, , Puerto Rico
Advance Medical Research Center
San Juan, , Puerto Rico
Countries
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References
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Rosenstock J, Hsia S, Nevarez Ruiz L, Eyde S, Cox D, Wu WS, Liu R, Li J, Fernandez Lando L, Denning M, Ludwig L, Chen Y; ACHIEVE-1 Trial Investigators. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes. N Engl J Med. 2025 Sep 18;393(11):1065-1076. doi: 10.1056/NEJMoa2505669. Epub 2025 Jun 21.
Related Links
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A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)
Other Identifiers
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J2A-MC-GZGT
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1290-5157
Identifier Type: OTHER
Identifier Source: secondary_id
18564
Identifier Type: -
Identifier Source: org_study_id
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