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NCT06109311CompletedPhase 3

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

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
546 (actual)
First submitted
26 Oct 2023
Start date
10 Nov 2023
Primary completion date
15 Sept 2025
Lead sponsor
Eli Lilly and Company
NCT number
NCT06109311
EU CT number
2023-507280-18-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 546
  • From 10 Nov 2023 to the primary completion date, 15 Sept 2025
  • 70 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 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.

Other illness

  • Have New York Heart Association functional classification III-IV 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

Other

  • Have had chronic or acute pancreatitis any time.

Who the study is looking for

  • Have Type 2 Diabetes (T2D)
  • 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.

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

Full criteria on ClinicalTrials.gov

Sites (70)

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

SiteCityCountrySite status
L2IP - Instituto de Pesquisas Clínicas
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BrasíliaBrazilUnknown status
Centro de Pesquisa Sao Lucas
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CampinasBrazilUnknown status
Quanta Diagnóstico e Terapia
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CuritibaBrazilUnknown status
Insight Centro de Pesquisas
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Porto AlegreBrazilUnknown status
IBPClin - Instituto Brasil de Pesquisa Clínica
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Rio de JaneiroBrazilUnknown status
Centro Multidisciplinar de Estudos Clinicos
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São Bernardo do CampoBrazilUnknown status
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
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São José dos CamposBrazilUnknown status
CPQuali Pesquisa Clínica
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São PauloBrazilUnknown status
CEDOES
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VitóriaBrazilUnknown status
Beijing Hospital
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BeijingChinaUnknown status
Chongqing General Hospital
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ChongqingChinaUnknown status
The Second People's Hospital of Hefei
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HefeiChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The First Affiliated Hospital of Henan University of Science &Technology
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Luoyang ShiChinaUnknown status
Nanjing First Hospital
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NanjingChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown 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
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
Matoba Internal Medicine Clinic
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EbinaJapanUnknown status
Takai Internal Medicine Clinic
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Kamakura-shiJapanUnknown status
Shiraiwa Medical Clinic
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KashiharaJapanUnknown status
Jinnouchi Hospital
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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
Medical Corporation Sato Medical clinic
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OotakuJapanUnknown status
Kansai Electric Power Hospital
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OsakaJapanUnknown status
Tama Center Clinic Mirai
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TamaJapanUnknown status
Centro de Endocrinologia y Nutricion
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CaguasPuerto RicoUnknown status
FDI Clinical Research
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San JuanPuerto RicoUnknown status
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
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BrasovRomaniaCompleted
Societatea Civila Medicala Dr. Paveliu
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BucharestRomaniaCompleted
Nutrilife S.R.L.
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BucharestRomaniaCompleted
Easydiet S.R.L.
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BucharestRomaniaCompleted
Milena Sante S.R.L.
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GalatiRomaniaCompleted
Diamed Obesity S.R.L.
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GalatiRomaniaCompleted
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia
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MaramureșRomaniaCompleted
Diabdana S.R.L.
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OradeaRomaniaCompleted
Clinica Korall S.R.L.
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Satu MareRomaniaCompleted
Dentosim-Queen S.R.L.
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Targu MuresRomaniaCompleted
Bingham Memorial Hospital
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BlackfootUnited StatesUnknown status
St. Luke's Humphreys Diabetes Center: Boise
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BoiseUnited StatesUnknown status
Care Access - Brandon
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BrandonUnited StatesUnknown status
SanRo Clinical Research Group
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BryantUnited StatesUnknown status
MD First Research - Chandler
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ChandlerUnited StatesUnknown status
Velocity Clinical Research, Mt. Auburn
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CincinnatiUnited StatesUnknown status
Orita Clinical Research
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DecaturUnited StatesUnknown status
Velocity Clinical Research, Gardena
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GardenaUnited StatesUnknown status
CMR of Greater New Haven, LLC
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HamdenUnited StatesUnknown status
Encore Medical Research
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HollywoodUnited StatesUnknown status
The Research Group of Lexington
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LexingtonUnited StatesUnknown status
Loma Linda University Health System
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Loma LindaUnited StatesUnknown status
Velocity Clinical Research, Medford
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MedfordUnited StatesUnknown status
Lifedoc Research - Lenox Park Drive
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MemphisUnited StatesUnknown status
Tristar Clinical Investigations
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PhiladelphiaUnited StatesUnknown status
Phoenix Clinical LLC
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PhoenixUnited StatesUnknown status
Western University of Health Sciences
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PomonaUnited StatesUnknown status
Frontier Clinical Research, LLC
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ScottdaleUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Clinvest Headlands LLC
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SpringfieldUnited StatesUnknown status
Richmond University Medical Center
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Staten IslandUnited StatesUnknown status
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc
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Toluca LakeUnited StatesUnknown status
Cotton O'Neil Diabetes & Endocrinology
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TopekaUnited StatesUnknown status
Texas Valley Clinical Research
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WeslacoUnited StatesUnknown status
Encore Medical Research - Weston
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WestonUnited StatesUnknown status

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