- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06916091
A Study of Eloralintide (LY3841136) in Chinese Participants With Obesity or Overweight
A Phase 1, Investigator- and Participant-Blinded, Placebo Controlled, Randomized, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Eloralintide (LY3841136) in Chinese Participants With Obesity or Overweight
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 138623
- Lilly Centre for Clinical Pharmacology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Placebo administered SC
|
Administered SC
|
|
Experimental: Eloralintide
Eloralintide administered subcutaneously (SC)
|
Administered subcutaneously (SC)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: 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
|
Baseline to Study Completion (Up to 10 Weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Eloralintide
Time Frame: Baseline to Study Completion (Up to 10 Weeks)
|
PK:Cmax of Eloralintide
|
Baseline to Study Completion (Up to 10 Weeks)
|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of Eloralintide
Time Frame: Baseline to Study Completion (Up to 10 Weeks)
|
PK: AUC of Eloralintide
|
Baseline to Study Completion (Up to 10 Weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27320
- J3R-MC-YDAD (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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