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Completed

NCT Number: NCT06297616

A Study of LY3841136 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

P-One Clinic, Hachiōji, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3841136

Drug

Administered SC

LY3841136-Placebo

Drug

Administered SC

Tirzepatide

Drug

Administered SC

Tirzepatide-Placebo

Drug

Administered SC

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

    Time frame: 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

    Time frame: 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

    Time frame: Predose through Week 22

    PK: AUC of LY3841136 alone

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

    Time frame: Predose through Week 22

    PK: Cmax of LY3841136 alone

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

    Time frame: Baseline through Week 12

    PD: Change from baseline in body weight

  4. Part B PK: AUC of LY3841136 in Combination with Tirzepatide

    Time frame: Predose through Week 34

    PK: AUC of LY3841136 in combination with tirzepatide

  5. Part B PK: Cmax of LY3841136 in Combination with Tirzepatide

    Time frame: 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

    Time frame: Baseline through Week 24

    PD: Change from baseline in body weight

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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