> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly3841136-in-japanese-participants-with-obesity-42565759-78a5-4f13-8a88-d6197bd7b99b > Record changed: 2026-11-04 # A Study of LY3841136 in Japanese Participants With Obesity or Overweight NCT06297616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) Participants 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) Start date 2024-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Title and summary **Summary** The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Short title** A Study of LY3841136 in Japanese Participants With Obesity or Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Official title** A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 Monotherapy, and LY3841136 in Combination With Tirzepatide, in Japanese Participants With Obesity or Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Dates **Completion date** 2025-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **First posted** 2024-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Registry last updated** 2026-01-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Primary completion date** 2025-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Start date** 2024-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Size and sites **Actual participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Identifiers **Registry ID** NCT06297616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **ClinicalTrials.gov ID** NCT06297616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## 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/NCT06297616) ## Outcomes ### Primary outcomes 1. Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22 Timeframe: Baseline through Week 22 A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module 2. Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34 Timeframe: Baseline through Week 34 A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module ### Secondary outcomes 1. Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136 Timeframe: Predose through Week 22 PK: AUC of LY3841136 alone 2. Part A PK: Maximum Observed Concentration (Cmax) of LY3841136 Timeframe: Predose through Week 22 PK: Cmax of LY3841136 alone 3. Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12 Timeframe: Baseline through Week 12 PD: Change from baseline in body weight 4. Part B PK: AUC of LY3841136 in Combination with Tirzepatide Timeframe: Predose through Week 34 PK: AUC of LY3841136 in combination with tirzepatide 5. Part B PK: Cmax of LY3841136 in Combination with Tirzepatide Timeframe: Predose through Week 34 PK: Cmax of LY3841136 in combination with tirzepatide 6. Part B PD: Change From Baseline in Body Weight at Week 24 Timeframe: Baseline through Week 24 PD: Change from baseline in body weight Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria - Male or female participants who agree to contraception requirements - Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive - Have had a stable weight for the 3 months ### Exclusion criteria - Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions - Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years - Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus - Have a history of chronic medical conditions involving the heart, liver, or kidneys - Have a history of any malignancy within the past 5 years - Have a history or presence of a GI disorder - Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity - Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening - For participants in Part B, have previously received tirzepatide within 6 months prior to screening - For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## Sites - P-One ClinicHachiōji, Japan - Sumida HospitalSumida-ku, Japan - Hakata ClinicFukuoka, Japan Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/466940) ### Other registry identifiers - J3R-JE-YDAB Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06297616) ## 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 (2) - [Metabolic disease](https://trialight.com/data/condition/metabolic-disease-3d73c19d-b8c8-5be8-add5-77c7d794dacd.md) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.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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