A Study of Eloralintide (LY3841136) in Chinese Participants With Obesity or Overweight

Phase 1

Not yet recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Eloralintide; Drug: Placebo

• Registration Number: NCT06916091
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eloralintide	Eloralintide	Eloralintide administered subcutaneously (SC)
Placebo	Placebo	Placebo administered SC

Primary Outcome Measures

Name	Time	Method
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	Baseline to Study Completion (Up to 10 Weeks)	A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Eloralintide	Baseline to Study Completion (Up to 10 Weeks)	PK:Cmax of Eloralintide
PK: Area Under the Concentration Versus Time Curve (AUC) of Eloralintide	Baseline to Study Completion (Up to 10 Weeks)	PK: AUC of Eloralintide

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore