> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-orforglipron-ly3502970-compared-with-semaglutide-38d86762-176a-480e-8fbb-9aa091417a93 > Record changed: 2026-10-13 # A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin NCT06045221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) Participants 1,698 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) Start date 2023-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) Number of sites 131 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Title and summary **Summary** The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Acronym** ACHIEVE-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Short title** A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Official title** A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Dates **Completion date** 2025-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **First posted** 2023-09-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Registry last updated** 2025-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Primary completion date** 2025-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Start date** 2023-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Size and sites **Actual participants** 1,698 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Participants** 1,698 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Number of sites** 131 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Identifiers **Registry ID** NCT06045221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **ClinicalTrials.gov ID** NCT06045221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Outcomes ### Primary outcomes 1. Change from Baseline in Hemoglobin A1c (HbA1c) Timeframe: Baseline, Week 52 ### Secondary outcomes 1. Change from Baseline in HbA1c Timeframe: Baseline, Week 52 2. Percentage of Participants Who Achieved HbA1c <7.0% 53 millimole/mole (mmol/mol) Timeframe: Week 52 3. Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol) Timeframe: Week 52 4. Percentage Change from Baseline in Body Weight Timeframe: Baseline, Week 52 5. Change from Baseline in Body Weight Timeframe: Baseline, Week 52 6. Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/mol) Timeframe: Week 52 7. Change from Baseline in Fasting Serum Glucose Timeframe: Baseline, Week 52 8. Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG) Timeframe: Baseline, Week 52 9. Percentage of Participants Who Achieved Weight Loss of ≥5% Timeframe: Week 52 10. Percentage of Participants Who Achieved Weight Loss of ≥10% Timeframe: Week 52 11. Percentage of Participants Who Achieved Weight Loss of ≥15% Timeframe: Week 52 12. Change from Baseline in Systolic Blood Pressure (SBP) Timeframe: Baseline, Week 52 13. Change from Baseline in Diastolic Blood Pressure (DBP) Timeframe: Baseline, Week 52 14. Percentage Change from Baseline in Total Cholesterol Timeframe: Baseline, Week 52 15. Percentage Change from Baseline in High Density Lipoprotein (HDL)-Cholesterol Timeframe: Baseline, Week 52 16. Percentage Change from Baseline in Low Density Lipoprotein (LDL)-Cholesterol Timeframe: Baseline, Week 52 17. Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-Cholesterol Timeframe: Baseline, Week 52 18. Percentage Change from Baseline in Non-HDL-Cholesterol Timeframe: Baseline, Week 52 19. Percentage Change from Baseline in Triglycerides Timeframe: Baseline, Week 52 20. Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores Timeframe: Baseline, Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Have Type 2 Diabetes - Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening. - Have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization. - Are of stable body 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 ### Exclusion criteria - Have Type 1 Diabetes - Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors. - Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization. - Have a New York Heart Association functional classification IV congestive heart failure. - Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening. - Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening. - Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Sites - Absolute Clinical ResearchPhoenix, United States - San Fernando Valley Health InstituteCanoga Park, United States - Neighborhood Healthcare Institute of HealthEscondido, United States - Velocity Clinical Research, GardenaGardena, United States - Biopharma Informatic, LLCLos Angeles, United States - Velocity Clinical Research, WestlakeLos Angeles, United States - Infinity Clinical Research - NorcoNorco, United States - Valley Clinical Trials, Inc.Northridge, United States - Norcal Endocrinology & Internal MedicineSan Ramon, United States - Encompass Clinical ResearchSpring Valley, United States - University Clinical Investigators, Inc.Tustin, United States - New West Physicians Clinical ResearchGolden, United States - Connecticut Clinical Research - CromwellCromwell, United States - Clinical Research of West Florida, Inc. (Clearwater)Clearwater, United States - South Florida Clinical Research InstituteMargate, United States - Miami Dade Medical Research Institute, LLCMiami, United States - West Orange EndocrinologyOcoee, United States - Latin Clinical Trial Center FloridaTamarac, United States - Clinical Research of West FloridaTampa, United States - Metabolic Research Institute, Inc.West Palm Beach, United States - Balanced Life Health Care Solutions/SKYCRNGLawrenceville, United States - Clinical Research AtlantaStockbridge, United States - North Georgia Clinical ResearchWoodstock, United States - Northwest Clinical TrialsBoise, United States - Family First Medical CenterIdaho Falls, United States And 106 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## References - PubMed 41765029 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41765029/) Related publication - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/424335) ### Other registry identifiers (2) - U1111-1290-6014 - J2A-MC-GZGU Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06045221) ## Related records ### Drugs (2) - [Orforglipron](https://trialight.com/data/asset/orforglipron-1138c12b-f1c7-45bb-b9ec-2b693f019a62.md) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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