A Study of LY3841136 in Japanese Participants With Obesity or Overweight

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Tirzepatide; Drug: LY3841136; Drug: Tirzepatide-Placebo; Drug: LY3841136-Placebo

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Hakata Clinic
  • Tokyo
    • Hachiōji, Tokyo, Japan, 192-0071
      • P-One Clinic
    • Sumida-ku, Tokyo, Japan, 130-0004
      • Sumida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: LY3841136; LY3841136 administered subcutaneously (SC)	Drug: LY3841136; Administered SC
Placebo Comparator: Part A: Placebo; Placebo administered SC	Drug: LY3841136-Placebo; Administered SC
Experimental: Part B: Tirzepatide + LY3841136-Placebo; Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC	Drug: Tirzepatide; Administered SC; Drug: LY3841136-Placebo; Administered SC
Experimental: Part B: LY3841136 + Tirzepatide-Placebo; LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC	Drug: LY3841136; Administered SC; Drug: Tirzepatide-Placebo; Administered SC
Experimental: Part B: LY3841136 + Tirzepatide; LY3841136 administered SC along with Tirzepatide administered SC	Drug: Tirzepatide; Administered SC; Drug: LY3841136; Administered SC
Placebo Comparator: Part B: LY3841136-Placebo + Tirzepatide-Placebo; Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC	Drug: Tirzepatide-Placebo; Administered SC; Drug: LY3841136-Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline through Week 22
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	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	Baseline through Week 34

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136	PK: AUC of LY3841136 alone	Predose through Week 22
Part A PK: Maximum Observed Concentration (Cmax) of LY3841136	PK: Cmax of LY3841136 alone	Predose through Week 22
Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12	PD: Change from baseline in body weight	Baseline through Week 12
Part B PK: AUC of LY3841136 in Combination with Tirzepatide	PK: AUC of LY3841136 in combination with tirzepatide	Predose through Week 34
Part B PK: Cmax of LY3841136 in Combination with Tirzepatide	PK: Cmax of LY3841136 in combination with tirzepatide	Predose through Week 34
Part B PD: Change From Baseline in Body Weight at Week 24	PD: Change from baseline in body weight	Baseline through Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3841136 in Japanese Participants with Obesity or Overweight

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): November 21, 2025
• Study Completion (Actual): November 21, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Metabolic Disorders; Obesity Disease; Body Weight Loss
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Metabolic Diseases; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: 18814; J3R-JE-YDAB (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No