A Study of LY3841136 in Healthy and Overweight Participants

NCT ID: NCT05295940

Last Updated: 2024-04-01

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

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2024-01-25

Brief Summary

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The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.

Detailed Description

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Conditions

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Obesity Healthy

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 (Part A)

Single ascending doses of LY3841136 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3841136

Intervention Type DRUG

Administered SC.

LY3841136 (Part B)

Multiple ascending doses of LY3841136 administered SC.

Group Type EXPERIMENTAL

LY3841136

Intervention Type DRUG

Administered SC.

Placebo (Part A)

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Placebo (Part B)

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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LY3841136

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
* Have had a stable weight for the last 3 months
* Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)

Exclusion Criteria

* Are women who are lactating
* Have known allergies to related compounds of LY3841136 or any components of the formulation
* Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Have been diagnosed with Type 1 or Type 2 diabetes mellitus
* Have a history of chronic medical conditions involving the heart, liver, or kidneys
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

References

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Briere DA, Qu H, Lansu K, He MM, Moyers JS, Coskun T, Long A, Allen D, O'Farrell L, Bowen B, Pratt E, Tidemann-Miller B, San Tham L, Ibriga H, Alsina-Fernandez J, Mather KJ, Haupt A, Bhattachar SN. Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept. Mol Metab. 2025 Oct 16:102271. doi: 10.1016/j.molmet.2025.102271. Online ahead of print.

Reference Type DERIVED
PMID: 41109426 (View on PubMed)

Other Identifiers

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J3R-MC-YDAA

Identifier Type: OTHER

Identifier Source: secondary_id

18309

Identifier Type: -

Identifier Source: org_study_id

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