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
- Diseases
- Type 2 diabetes
- 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
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| L2IP - Instituto de Pesquisas Clínicas Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Quanta Diagnóstico e Terapia Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Insight Centro de Pesquisas Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| IBPClin - Instituto Brasil de Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Centro Multidisciplinar de Estudos Clinicos Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Unknown status |
| ISPEM - Instituto São José dos Campos em Pesquisas Médicas Coordinator of this site? Confirm its status | São José dos Campos | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chongqing General Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The Second People's Hospital of Hefei Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science &Technology Coordinator of this site? Confirm its status | Luoyang Shi | China | Unknown status |
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Wannan Medical College Yijishan Hospital Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Hasegawa Medical Clinic Coordinator of this site? Confirm its status | Chitose | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| The Institute of Medical Science, Asahi Life Foundation Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Matoba Internal Medicine Clinic Coordinator of this site? Confirm its status | Ebina | Japan | Unknown status |
| Takai Internal Medicine Clinic Coordinator of this site? Confirm its status | Kamakura-shi | Japan | Unknown status |
| Shiraiwa Medical Clinic Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Jinnouchi Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Tokuyama Clinic Coordinator of this site? Confirm its status | Mihama-ku,Chiba City | Japan | Unknown status |
| MinamiAkatsukaClinic Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Abe Clinic Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Medical Corporation Sato Medical clinic Coordinator of this site? Confirm its status | Ootaku | Japan | Unknown status |
| Kansai Electric Power Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Tama Center Clinic Mirai Coordinator of this site? Confirm its status | Tama | Japan | Unknown status |
| Centro de Endocrinologia y Nutricion Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| FDI Clinical Research Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Completed |
| Societatea Civila Medicala Dr. Paveliu Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Nutrilife S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Easydiet S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Milena Sante S.R.L. Coordinator of this site? Confirm its status | Galati | Romania | Completed |
| Diamed Obesity S.R.L. Coordinator of this site? Confirm its status | Galati | Romania | Completed |
| Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia Coordinator of this site? Confirm its status | Maramureș | Romania | Completed |
| Diabdana S.R.L. Coordinator of this site? Confirm its status | Oradea | Romania | Completed |
| Clinica Korall S.R.L. Coordinator of this site? Confirm its status | Satu Mare | Romania | Completed |
| Dentosim-Queen S.R.L. Coordinator of this site? Confirm its status | Targu Mures | Romania | Completed |
| Bingham Memorial Hospital Coordinator of this site? Confirm its status | Blackfoot | United States | Unknown status |
| St. Luke's Humphreys Diabetes Center: Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Care Access - Brandon Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| SanRo Clinical Research Group Coordinator of this site? Confirm its status | Bryant | United States | Unknown status |
| MD First Research - Chandler Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Velocity Clinical Research, Mt. Auburn Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Orita Clinical Research Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Velocity Clinical Research, Gardena Coordinator of this site? Confirm its status | Gardena | United States | Unknown status |
| CMR of Greater New Haven, LLC Coordinator of this site? Confirm its status | Hamden | United States | Unknown status |
| Encore Medical Research Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| The Research Group of Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Loma Linda University Health System Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Velocity Clinical Research, Medford Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| Lifedoc Research - Lenox Park Drive Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Tristar Clinical Investigations Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Phoenix Clinical LLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Western University of Health Sciences Coordinator of this site? Confirm its status | Pomona | United States | Unknown status |
| Frontier Clinical Research, LLC Coordinator of this site? Confirm its status | Scottdale | United States | Unknown status |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Clinvest Headlands LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Richmond University Medical Center Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc Coordinator of this site? Confirm its status | Toluca Lake | United States | Unknown status |
| Cotton O'Neil Diabetes & Endocrinology Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Unknown status |
| Encore Medical Research - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
Related publications
- Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial.JAMA · 2026 · PMID 42251769
This page is information, not medical advice. Discuss any trial with your doctor.