> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-eloralintide-ly3841136-and-eloralintide-with-329521e3-f0fe-42eb-bf9f-ea208159cef4 > Record changed: 2026-10-13 # A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity NCT06916065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) Participants 188 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) Start date 2025-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Title and summary **Summary** The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it. There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Short title** A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Official title** A Phase 1, Open-Label, Single and Multiple Dose Study to Investigate the Safety, Tolerability, and Relative Bioavailability of Single and Multiple Weekly Subcutaneous Doses of Eloralintide, and Single and Multiple Weekly Subcutaneous Doses of Eloralintide With Tirzepatide in Participants With Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Dates **Completion date** 2026-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **First posted** 2025-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Registry last updated** 2026-01-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Primary completion date** 2026-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Start date** 2025-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Size and sites **Actual participants** 188 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Participants** 188 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Identifiers **Registry ID** NCT06916065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **ClinicalTrials.gov ID** NCT06916065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Outcomes ### Primary outcomes 1. Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide Timeframe: Day 106 Predose to Approximately Week 26 PK: AUC of Eloralintide and Tirzepatide 2. Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide Timeframe: Day 106 Predose to Approximately Week 26 PK: Cmax of Eloralintide and Tirzepatide 3. Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide Timeframe: Baseline Up to Approximately Week 11 PK: AUC of Eloralintide and Tirzepatide 4. Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide Timeframe: Baseline Up to Approximately Week 11 PK: Cmax of Eloralintide and Tirzepatide 5. Cohorts E and F: PK: AUC of Eloralintide Timeframe: Day 8 Predose Up to Approximately Week 12 PK: AUC of Eloralintide 6. Cohorts E and F: PK: Cmax of Eloralintide Timeframe: Day 8 Predose Up to Approximately Week 12 PK: Cmax of Eloralintide 7. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Timeframe: Baseline Up to Approximately Week 26 A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria - Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Participants with a history of thyroid disease or on thyroid medication will need to be biochemically euthyroid as assessed by measuring thyroid stimulating hormone at screening - Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive - Have had a stable weight for the 3 months prior to screening, that is, less than 5% body weight change ### Exclusion criteria - Have known allergies to related compounds of eloralintide or tirzepatide, or any of the components of the formulations - Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data - Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol/mol) - Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years - Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis - Have obesity induced by other endocrinologic disorders for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity for example, Melanocortin 4 Receptor deficiency or Prader Willi syndrome - Have a history of hypocalcemia or hypercalcemia, or abnormal laboratory values for calcium or serum phosphorus - Have a medical history or current evidence of clinically significant cardiac condition, as per the investigator, including: - second or third degree heart block - sick sinus syndrome - peripheral arterial circulatory disorders - valvular disease - cardiomyopathy, or - other clinically significant cardiac condition - Have taken approved or investigational medication for weight loss, including GLP-1 RAs, within the previous 3 months of study screening - Intend to use any weight loss medications during study participation Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Sites - Anaheim Clinical Trials, LLCAnaheim, United States - Fortrea Clinical Research UnitDaytona Beach, United States - Fortrea Clinical Research UnitDallas, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/590708) ### Other registry identifiers - J3R-MC-YDAE Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06916065) ## Related records ### Drugs (2) - [Eloralintide](https://trialight.com/data/asset/eloralintide-ccf70d16-4bb8-42b3-b3e3-491d8fbd44a8.md) - [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 (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) ### 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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