> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-investigational-tirzepatide-ly3298176-doses-in-b94b5dcc-8ecd-4ed3-a316-a6c23699ac39 > Record changed: 2026-10-13 # A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity NCT06037252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) Participants 414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) Start date 2023-09-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) Number of sites 40 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Title and summary **Summary** The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Short title** A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Official title** A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Dates **Completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **First posted** 2023-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Registry last updated** 2026-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Primary completion date** 2026-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Start date** 2023-09-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Size and sites **Actual participants** 414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Participants** 414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Number of sites** 40 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Identifiers **Registry ID** NCT06037252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **ClinicalTrials.gov ID** NCT06037252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Outcomes ### Primary outcomes 1. Percent Change From Baseline in Body Weight Timeframe: Baseline (Week 0), Week 44 ### Secondary outcomes 1. Change from Baseline in HbA1c Timeframe: Baseline (Week 0), Week 44 2. Change from Baseline in HbA1c Timeframe: Baseline (Week 24), Week 80 3. Percent Change from Baseline in Body Weight Timeframe: Baseline (Week 24), Week 80 4. Absolute Change from Baseline in Body Weight Timeframe: Baseline (Week 0), Week 44 5. Absolute Change from Baseline in Body Weight Timeframe: Baseline (Week 24), Week 80 6. Change from Baseline in Body Mass Index (BMI) Timeframe: Baseline (Week 0), Week 44 7. Change from Baseline in BMI Timeframe: Baseline (Week 24), Week 80 8. Change from Baseline in Waist Circumference Timeframe: Baseline (Week 0), Week 44 9. Change from Baseline in Waist Circumference Timeframe: Baseline (Week 24), Week 80 10. Percentage of Participants Achieving ≥15% Body Weight Reduction Timeframe: Baseline (Week 0), Week 44 11. Percentage of Participants Achieving ≥15% Body Weight Reduction Timeframe: Baseline (Week 0), Week 80 12. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) Timeframe: Baseline through Week 44 Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening. - Have had stable body weight (±5%) during the 90 days preceding screening. - Have been diagnosed with Type 2 Diabetes (T2D). - Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day. ### Exclusion criteria - Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. - Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening. - Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. - Have a prior or planned surgical treatment for obesity. - Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening. - Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m². - Have any of the following cardiovascular (CV) conditions within 2 months prior to screening. - acute myocardial infarction. - cerebrovascular accident (stroke). - unstable angina . - hospitalization due to congestive heart failure, or - coronary artery revascularization. - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. - Have a history of chronic or acute pancreatitis. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Sites - Medical Advancement Centers of ArizonaPhoenix, United States - John Muir Physician Network Research CenterConcord, United States - Care Access - SacramentoSacramento, United States - Care Access - AuroraAurora, United States - Chase Medical Research, LLCWaterbury, United States - Retreat Medical ResearchMiami, United States - American Research Centers of FloridaPembroke Pines, United States - Alta Pharmaceutical Research CenterNorcross, United States - AGILE Clinical Research Trials, LLCSandy Springs, United States - Northwestern UniversityChicago, United States - Qualmedica Research, LLCEvansville, United States - Integrated Clinical Trial Services, Inc.West Des Moines, United States - Accellacare - Wilmington - 1917 Tradd CourtWilmington, United States - Velocity Clinical Research, Mt. AuburnCincinnati, United States - Summit HeadlandsPortland, United States - Clinical Research Associates IncNashville, United States - Juno ResearchHouston, United States - Southern Endocrinology AssociatesMesquite, United States - Charlottesville Medical ResearchCharlottesville, United States - Northwest Clinical Research CenterBellevue, United States - CEDICCABA, Argentina - Consultorio de Investigación Clínica EMO SRLCiudad Autonoma de Buenos Aires, Argentina - Centro Médico ViamonteBuenos Aires, Argentina - Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaBuenos Aires, Argentina - Centro de Investigaciones Metabólicas (CINME)Buenos Aires, Argentina And 15 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/422915) ### Other registry identifiers (3) - 2023 - 2023-504561-24-00 - I8F-MC-GPIT Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06037252) ## Related records ### Drugs (1) - [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (6) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) - [Endocrine system disorder](https://trialight.com/data/condition/endocrine-system-disorder-7bab6998-7c2b-586b-940e-d8d567288d52.md) - [Glucose metabolism disease](https://trialight.com/data/condition/glucose-metabolism-disease-e258cc9e-1eda-56cb-80f3-f4bd7a42bc71.md) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) - [Overnutrition](https://trialight.com/data/condition/overnutrition-316d9ad8-158c-5803-9f22-091a112d1f89.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (2) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [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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