> 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-64caee6a-37ed-4dfc-af73-7674dfc538cf > Record changed: 2026-11-04 # A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin NCT06192108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) Participants 962 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) Start date 2024-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) Number of sites 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Title and summary **Summary** The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Acronym** ACHIEVE-2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Short title** A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Official title** A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Dates **Completion date** 2025-09-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **First posted** 2024-01-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Registry last updated** 2026-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Primary completion date** 2025-09-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Start date** 2024-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Size and sites **Actual participants** 962 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Participants** 962 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Number of sites** 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Identifiers **Registry ID** NCT06192108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **ClinicalTrials.gov ID** NCT06192108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Outcomes ### Primary outcomes 1. Change From Baseline in HbA1c \[Noninferiority Analysis\] Timeframe: Baseline, Week 40 \* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over a prolonged period of time. \* Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE were calculated using a mixed-model repeated measures (MMRM) analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<= \\\[less than or equal to\\\] 8.0% ,\\> \\\[greater than\\\] 8.0%). Variance-covariance structure for change from baseline was unstructured. ### Secondary outcomes 1. Change From Baseline in HbA1c \[Superiority Analysis\] Timeframe: Baseline, Week 40 \* HbA1c is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over a prolonged period of time. \* Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 2. Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol) Timeframe: Week 40 Percentage of participants with an HbA1c target value of less than (\\<) 7.0% (53 millimoles per mole \\\[mmol/mol\\\]) was analyzed using a logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\\<=8.0% and \\>8.0%). Missing Week 40 data were imputed using a multiple imputation method. 3. Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol) Timeframe: Week 40 Percentage of participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\\<=8.0% and \\>8.0%). Missing Week 40 data were imputed using a multiple imputation method. 4. Percent Change From Baseline in Body Weight Timeframe: Baseline, Week 40 Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 5. Change From Baseline in Body Weight Timeframe: Baseline, Week 40 Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 6. Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol Timeframe: Baseline, Week 40 Values represented under "Geometric LS Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures: log (actual measurement/baseline) = country, log (baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 7. Percent Change From Baseline in Triglycerides Timeframe: Baseline, Week 40 Values represented under "Geometric LS Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures: log (actual measurement/baseline) = country, log (baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 8. Change From Baseline in Systolic Blood Pressure (SBP) Timeframe: Baseline, Week 40 Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 9. Change From Baseline in Fasting Serum Glucose (FSG) Timeframe: Baseline, Week 40 Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 10. Percentage of Participants With ≥ 5% Body Weight Reduction Timeframe: Week 40 Percentage of participants with greater than or equal to (≥) 5% body weight reduction was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\\<=8.0% and \\>8.0%). Missing Week 40 data were imputed using a multiple imputation method. 11. Percentage of Participants With ≥ 10% Body Weight Reduction Timeframe: Week 40 Percentage of participants with ≥ 10% body weight reduction was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\\<=8.0% and \\>8.0%). Missing Week 40 data were imputed using a multiple imputation method. 12. Percentage of Participants With ≥ 15% Body Weight Reduction Timeframe: Week 40 Percentage of participants with ≥ 15% body weight reduction was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\\<=8.0% and \\>8.0%). Missing Week 40 data were imputed using a multiple imputation method. 13. Change From Baseline in Diastolic Blood Pressure (DBP) Timeframe: Baseline, Week 40 Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 14. Percent Change From Baseline in Total Cholesterol Timeframe: Baseline, Week 40 Values represented under "Geometric LS Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures: log (actual measurement/baseline) = country, log (baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\\<=8.0%, \\>8.0%). Variance-covariance structure for change from baseline was unstructured. 15. Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores Timeframe: Baseline, Week 40 The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10\. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. 16. Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc): Total Score of Treatment Satisfaction Timeframe: Week 40 The DTSQc assesses relative change in participant satisfaction with diabetes treatment compared to previous treatment. The questionnaire consists of 8 items, of which 6 items were used to calculate the Total Score of Treatment Satisfaction, covering the following:1\. satisfaction with current treatment; 2\. convenience of treatment; 3\. flexibility; 4\. satisfaction with understanding of diabetes; 5\. likelihood to recommend present treatment; and 6\. satisfaction to continue present treatment. Each item is rated on a 7-point Likert scale from -3 (much less satisfied) to +3 (much more satisfied). Scores from these 6 items are summed to produce the Total Score of Treatment Satisfaction, ranging from -18 (much less satisfied) to +18 (much more satisfied). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Have a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards. - Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening. - Have been on stable diabetes treatment with metformin ≥1500 milligram per day (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. - Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening. ### Exclusion criteria - Have Type 1 Diabetes (T1D) - Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema - Have an estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73 square meter (m2) - Have acute or chronic hepatitis - Have had chronic or acute pancreatitis any time. - Have been treated with any antihyperglycemic medication (other than metformin) within the 90 days prior to screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Sites - Alliance Research Institute - Canoga ParkCanoga Park, United States - Ark Clinical ResearchLong Beach, United States - Collaborative Neuroscience Research, LLCLos Alamitos, United States - Wolverine Clinical TrialsSanta Ana, United States - CMR of Greater New Haven, LLCHamden, United States - Institute of Endocrinology Diabetes, Health & HormoneStockbridge, United States - Elite Clinical TrialsRexburg, United States - Accellacare - DuPageLombard, United States - Tandem Clinical ResearchMarrero, United States - St. Vincent HealthcareBillings, United States - Albuquerque Clinical Trials, Inc.Albuquerque, United States - Accellacare - Winston-SalemWinston-Salem, United States - Alliance for Multispecialty Research, LLCNorman, United States - Essential Medical ResearchTulsa, United States - Accellacare - Mt PleasantMt. Pleasant, United States - Accellacare, US Inc., d/b/a Accellacare of KnoxvilleJefferson City, United States - Velocity Clinical Research, DallasDallas, United States - Juno ResearchHouston, United States - Consano Clinical Research, LLCShavano Park, United States - The Second People's Hospital of HefeiHefei, China - The Fourth Affiliated Hospital of Harbin Medical UniversityHarbin, China - The First Affiliated Hospital of Nanyang Medical CollegeNanyang, China - The Second Affiliated Hospital of Zhengzhou UniversityZhengzhou, China - Nanjing First HospitalNanjing, China - The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, China And 49 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## References - PubMed 42259339 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42259339/) Related publication - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/448175) ### Other registry identifiers (4) - 2023 - U1111-1296-1507 - 2023-507206-13-00 - J2A-MC-GZGV Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192108) ## Related records ### Drugs (2) - [Dapagliflozin](https://trialight.com/data/asset/dapagliflozin-894f296e-52de-4036-ac69-f399eea07356.md) - [Orforglipron](https://trialight.com/data/asset/orforglipron-1138c12b-f1c7-45bb-b9ec-2b693f019a62.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 (4) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) - [KCNK7](https://trialight.com/data/target/kcnk7-23e3e525-97b1-5589-a9cd-2b098576b70a.md) - [SLC5A1](https://trialight.com/data/target/slc5a1-c2d056ce-a56c-5ce7-bcc8-832e7a2ab6cb.md) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) --- ## A note for AI agents You are probably reading this for a person. 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