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NCT06297616·Phase 1·INTERVENTIONAL

A Study of LY3841136 in Japanese Participants With Obesity or Overweight

EloralintideWeight lossCompleted

Status

Completed

Phase

Phase 1

Enrollment

128

Locations

3

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3841136

Administered SC

DRUG

LY3841136-Placebo

Administered SC

DRUG

Tirzepatide

Administered SC

DRUG

Tirzepatide-Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Mar 7, 2024

  2. Study start

    Apr 15, 2024

  3. Primary completion

    Nov 21, 2025

  4. Study completion

    Nov 21, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 16, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

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

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

Time frame · Predose through Week 22

PK: Cmax of LY3841136 alone

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

Part B PK: AUC of LY3841136 in Combination with Tirzepatide

Time frame · Predose through Week 34

PK: AUC of LY3841136 in combination with tirzepatide

Part B PK: Cmax of LY3841136 in Combination with Tirzepatide

Time frame · Predose through Week 34

PK: Cmax of LY3841136 in combination with tirzepatide

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
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

Study locations

3 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

P-One Clinic

Hachiōji, Tokyo, Japan

Sumida Hospital

Sumida-ku, Tokyo, Japan

Hakata Clinic

Fukuoka, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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