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NCT05971940CompletedPhase 3

A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
559 (actual)
First submitted
25 Jul 2023
Start date
9 Aug 2023
Primary completion date
3 Apr 2025
Lead sponsor
Eli Lilly and Company
NCT number
NCT05971940

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 559
  • From 9 Aug 2023 to the primary completion date, 3 Apr 2025
  • 89 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Have Type 1 Diabetes
  • Have New York Heart Association functional classification IV congestive heart failure.

Other

  • Have acute or chronic pancreatitis

Who the study is looking for

  • Have Type 2 Diabetes
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Hospital
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BeijingChinaUnknown status
Luhe Hospital
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BeijingChinaUnknown status
Beijing Pinggu District Hospital
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BeijingChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Shunde Hospital of Southern Medical Univesity
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FoshanChinaUnknown status
The Fourth Affiliated Hospital of Harbin Medical University
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HarbinChinaUnknown status
Huizhou Municipal Central Hospital
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HuizhouChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
Nanjing First Hospital
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NanjingChinaUnknown status
Nanyang First People's Hospital
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NanyangChinaUnknown status
Pudong New Area People's Hospital Shanghai
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ShanghaiChinaUnknown status
Wannan Medical College Yijishan Hospital
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WuhuChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status
Medstar Speciality Hospital
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BangaloreIndiaUnknown status
M S Ramaiah Medical College and Hospitals
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BangaloreIndiaUnknown status
Madras Diabetes Research Foundation
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ChennaiIndiaUnknown status
Kumudini Devi Diabetes Research Center
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HyderabadIndiaUnknown status
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
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KolkataIndiaUnknown status
BSES MG hospital
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MumbaiIndiaUnknown status
All India Institute of Medical Sciences (AIIMS) - Nagpur
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NagpurIndiaUnknown status
Grant Medical Foundation Ruby Hall Clinic
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PuneIndiaUnknown status
GMERS Medical College and General Hospital
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VadodaraIndiaUnknown status
Hayashi Diabetes Internal Medicine Clinic
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ChigasakiJapanUnknown status
Hasegawa Medical Clinic
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ChitoseJapanUnknown status
Tokyo-Eki Center-building Clinic
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Chuo-kuJapanUnknown status
Fukuwa Clinic
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Chuo-kuJapanUnknown status
The Institute of Medical Science, Asahi Life Foundation
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Chuo-kuJapanUnknown status
Steel Memorial Yahata Hospital
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KitakyushuJapanUnknown status
Morinaga Ueno Clinic
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KumamotoJapanUnknown status
Tokuyama Clinic
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Mihama-ku,Chiba CityJapanUnknown status
MinamiAkatsukaClinic
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MitoJapanUnknown status
Abe Clinic
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ŌitaJapanUnknown status
Heishinkai Medical Group ToCROM Clinic
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Shinjuku-kuJapanUnknown status
Medical Corporation Heishinkai OCROM Clinic
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Suita-shiJapanUnknown status
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
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Yamato-shiJapanUnknown status
Iwamoto Clinic
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ZentsujichóJapanUnknown status
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
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Chihuahua CityMexicoUnknown status
Centro de Investigacion Medica Integral
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GuadalajaraMexicoUnknown status
Salud Cardiovascular
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GuadalajaraMexicoUnknown status
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
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GuadalajaraMexicoUnknown status
PanAmerican Clinical Research - Querétaro - Avenida Antea
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QuerétaroMexicoUnknown status
Instituto Veracruzano en Investigación Clínica S.C.
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VeracruzMexicoUnknown status
FAICIC S. de R.L. de C.V.
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VeracruzMexicoUnknown status
Centro de Investigacion Medica de Occidente, S.C.
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ZapopanMexicoUnknown status
Puerto Rico Health Institute
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DoradoPuerto RicoUnknown status
Advance Medical Research Center
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San JuanPuerto RicoUnknown status
Billings Clinic
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BillingsUnited StatesUnknown status
Ellipsis Research Group - Brooklyn - 7th Street
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BrooklynUnited StatesUnknown status
Burke Internal Medicine and Research
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BurkeUnited StatesUnknown status
Invictus Clinical Research Group
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Coconut CreekUnited StatesUnknown status
The Corvallis Clinic, P.C.
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CorvallisUnited StatesUnknown status
Connecticut Clinical Research - Cromwell
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CromwellUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
Revival Research Institute
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DearbornUnited StatesUnknown status
Hillcrest Medical Research
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DeLandUnited StatesUnknown status
Centricity Research Dublin Multispecialty
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DublinUnited StatesUnknown status
Neighborhood Healthcare Institute of Health
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EscondidoUnited StatesUnknown status
The Research Center of the Upstate
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GreenvilleUnited StatesUnknown status
Endocrine Ips, Pllc
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HoustonUnited StatesUnknown status
Amir A Hassan, MD, PA
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HoustonUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
Velocity Clinical Research-Huntington Park
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Huntington ParkUnited StatesUnknown status
Family First Medical Center
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Idaho FallsUnited StatesUnknown status
The Jackson Clinic
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JacksonUnited StatesUnknown status
MDFirst Research, LLC
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LancasterUnited StatesUnknown status
Ark Clinical Research
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Long BeachUnited StatesUnknown status
Velocity Clinical Research, Westlake
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Los AngelesUnited StatesUnknown status
K2 Medical Research
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MaitlandUnited StatesUnknown status
Central New York Clinical Research
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ManliusUnited StatesUnknown status
Global Health Research Center, Inc.
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Miami LakesUnited StatesUnknown status
Monroe Biomedical Research
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MonroeUnited StatesUnknown status
American Health Network of Indiana, LLC - Muncie
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MuncieUnited StatesUnknown status
Lucas Research - New Bern
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New BernUnited StatesUnknown status
Alliance for Multispecialty Research, LLC
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New OrleansUnited StatesUnknown status
Infinity Clinical Research - Norco
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NorcoUnited StatesUnknown status
Alliance for Multispecialty Research, LLC
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NormanUnited StatesUnknown status
West Orange Endocrinology
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OcoeeUnited StatesUnknown status
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
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PittsburghUnited StatesUnknown status
Norcal Endocrinology & Internal Medicine
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San RamonUnited StatesUnknown status
Syed Research Consultants Llc
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SheffieldUnited StatesUnknown status
Clinical Research Atlanta
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StockbridgeUnited StatesUnknown status
Epic Medical Research - Surprise
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SurpriseUnited StatesUnknown status
Quality of Life Medical & Research Center
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TucsonUnited StatesUnknown status
University Clinical Investigators, Inc.
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TustinUnited StatesUnknown status
Rophe Adult and Pediatric Medicine/SKYCRNG
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Union CityUnited StatesUnknown status
Preferred Primary Care Physicians
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UniontownUnited StatesUnknown status
Tekton Research - Wichita
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WichitaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.