NCT05295940

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Mar 2022

Typical duration for phase_1 obesity

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

March 24, 2022

Last Update Submit

March 29, 2024

Conditions

ObesityHealthy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Predose up to 14 weeks (Part A) & 28 weeks (Part B)

Secondary Outcomes (3)

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

    Predose through week 14 (Part A) & week 28 (Part B)

  • PK: Maximum Observed Concentration (Cmax) of LY3841136

    Predose through week 14 (Part A) & week 28 (Part B)

  • Pharmacodynamics (PD): Change From Baseline in Body Weight

    Predose through week 28

Study Arms (4)

LY3841136 (Part A)

EXPERIMENTAL

Single ascending doses of LY3841136 administered subcutaneously (SC).

Drug: LY3841136

LY3841136 (Part B)

EXPERIMENTAL

Multiple ascending doses of LY3841136 administered SC.

Drug: LY3841136

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3841136DRUG

Administered SC.

LY3841136 (Part A)LY3841136 (Part B)
PlaceboDRUG

Administered SC.

Placebo (Part A)Placebo (Part B)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

  • 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, Tham LS, 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 Dec;102:102271. doi: 10.1016/j.molmet.2025.102271. Epub 2025 Oct 16.

    PMID: 41109426DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

March 25, 2022

Study Start

March 30, 2022

Primary Completion

January 25, 2024

Study Completion

January 25, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)