A Study of LY3841136 in Overweight and Obese Participants

NCT ID: NCT06345066

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2025-09-29

Brief Summary

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The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3841136 + Tirzepatide

LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC.

LY3841136

Intervention Type DRUG

Administered SC.

Placebo + Tirzepatide

Placebo administered SC in combination with tirzepatide given SC.

Group Type PLACEBO_COMPARATOR

Tirzepatide

Intervention Type DRUG

Administered SC.

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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Tirzepatide

Administered SC.

Intervention Type DRUG

LY3841136

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²).
* Have clinical laboratory test results within normal reference range
* Have venous access sufficient to allow for blood sampling
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria

* Have type 1 or type 2 diabetes mellitus
* Have an abnormal 12-lead electrocardiogram (ECG)
* Have a history or presence of psychiatric disorders
* Have abnormal blood pressure and pulse rate
* Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Fortrea Clinical Research Unit

Daytona Beach, Florida, United States

Site Status

Fortrea Clinical Research Unit

Dallas, Texas, United States

Site Status

Fortrea Clinical Research Unit

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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J3R-MC-YDAC

Identifier Type: OTHER

Identifier Source: secondary_id

18834

Identifier Type: -

Identifier Source: org_study_id

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