NCT06916091

Brief Summary

The purpose of this study is to evaluate how well Eloralintide (LY3841136) is tolerated and what side effects may occur in overweight and obese Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much Eloralintide gets into the bloodstream and how long it takes the body to eliminate it. The study will last approximately 10 weeks excluding a screening period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

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

April 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

April 21, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

April 1, 2025

Last Update Submit

November 18, 2025

Conditions

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 and SAEs regardless of causality, will be reported in the Reported Adverse Events module

    Baseline to Study Completion (Up to 10 Weeks)

Secondary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Eloralintide

    Baseline to Study Completion (Up to 10 Weeks)

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

    Baseline to Study Completion (Up to 10 Weeks)

Study Arms (2)

Eloralintide

EXPERIMENTAL

Eloralintide administered subcutaneously (SC)

Drug: Eloralintide

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

Administered subcutaneously (SC)

Also known as: LY3841136
Eloralintide

Administered SC

Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese participants. To qualify as Chinese, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
  • Have had a stable body weight for 3 months prior to screening. Participants with body weight change of less than 5% will be allowed
  • Have not modified diet or adopted any nutritional lifestyle modification for 3 months before randomization
  • Have clinical laboratory test results within a normal range for the population or investigative site at screening and lead-in, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Have a body mass index (BMI) within the range 27 to 40 kilogram per square meter (kg/m²)

You may not qualify if:

  • Are pregnant, or intend to become pregnant or to breastfeed during the study
  • Have known allergies to related compounds of eloralintide
  • Have any of the following abnormal blood pressure (BP) and/or pulse rate at screening, constituting a risk when taking the investigational product with minor deviations judged to be acceptable by the investigator:
  • Supine BP \> 160/90 millimeter mercury (mmHg)
  • Supine pulse rate \< 50 or \> 100 beats per minute (bpm)
  • Orthostatic hypotension
  • Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Regularly use known drugs of abuse and/or show positive findings on drug screening that are not consistent with the medical history or concomitant medication history
  • Have donated blood of more than 450 mL within the previous 3 months of study screening, or intend to donate blood during the course of the study
  • Have a history of chronic medical conditions involving the heart, liver, or kidneys
  • Have a medical history or current evidence of clinically significant cardiac condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Links

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979)

    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

April 1, 2025

First Posted

April 8, 2025

Study Start

April 21, 2025

Primary Completion

September 9, 2025

Study Completion

September 9, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations