A Study of LY3841136 in Japanese Participants With Obesity or Overweight

NCT06297616 | Completed Phase 1

• 2 other identifiers: 18814J3R-JE-YDAB
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Overweight; Obesity

Keywords

Obesity Disease; Metabolic Disorders; Body Weight Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136

  Predose through Week 22

• Part A PK: Maximum Observed Concentration (Cmax) of LY3841136

  Predose through Week 22

• Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12

  Baseline through Week 12

• Part B PK: AUC of LY3841136 in Combination with Tirzepatide

  Predose through Week 34

• Part B PK: Cmax of LY3841136 in Combination with Tirzepatide

  Predose through Week 34

Study Arms (6)

Part A: LY3841136

EXPERIMENTAL

LY3841136 administered subcutaneously (SC)

Drug: LY3841136

Part A: Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: LY3841136-Placebo

Part B: Tirzepatide + LY3841136-Placebo

EXPERIMENTAL

Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC

Drug: LY3841136-Placebo; Drug: Tirzepatide

Part B: LY3841136 + Tirzepatide-Placebo

EXPERIMENTAL

LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC

Drug: LY3841136; Drug: Tirzepatide-Placebo

Part B: LY3841136 + Tirzepatide

EXPERIMENTAL

LY3841136 administered SC along with Tirzepatide administered SC

Drug: LY3841136; Drug: Tirzepatide

Part B: LY3841136-Placebo + Tirzepatide-Placebo

PLACEBO COMPARATOR

Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC

Drug: LY3841136-Placebo; Drug: Tirzepatide-Placebo

Interventions

LY3841136-Placebo DRUG

Administered SC

Part A: Placebo; Part B: LY3841136-Placebo + Tirzepatide-Placebo; Part B: Tirzepatide + LY3841136-Placebo

Tirzepatide DRUG

Administered SC

Part B: LY3841136 + Tirzepatide; Part B: Tirzepatide + LY3841136-Placebo

Tirzepatide-Placebo DRUG

Administered SC

Part B: LY3841136 + Tirzepatide-Placebo; Part B: LY3841136-Placebo + Tirzepatide-Placebo

LY3841136 DRUG

Administered SC

Part A: LY3841136; Part B: LY3841136 + Tirzepatide; Part B: LY3841136 + Tirzepatide-Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

Sumida Hospital

Sumida-ku, Tokyo, 130-0004, Japan

Location

Hakata Clinic

Fukuoka, 812-0025, Japan

Location

Related Links

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

MeSH Terms

Conditions

Obesity; Overweight; Metabolic Diseases

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 15, 2024
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)