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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAD | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide | Experimental | Eloralintide administered subcutaneously (SC) |
|
| Placebo | Placebo Comparator | Placebo administered SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eloralintide | Drug | Administered subcutaneously (SC) |
|
|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Eloralintide | PK:Cmax of Eloralintide | Baseline to Study Completion (Up to 10 Weeks) |
| PK: Area Under the Concentration Versus Time Curve (AUC) of Eloralintide |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Contact Lilly at 1-800-LillyRx (1-800-545-5979) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | Administered SC |
|
PK: AUC of Eloralintide
| Baseline to Study Completion (Up to 10 Weeks) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |