A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants
Study Details
Study Description
Brief Summary
This study is being conducted to determine the side effects related to LY3437943 given as a single injection under the skin to healthy participants. Blood tests will be performed to check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3437943 or placebo. The study will last up to approximately 71 days for each participant, including screening.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY3437943 Escalating doses of LY3437943 administered as an injection under the skin in healthy participants |
Drug: LY3437943
Administered subcutaneously (SC)
|
Placebo Comparator: Placebo Matching placebo administered as an injection under the skin in healthy participants |
Drug: Placebo
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through final follow-up at approximately Day 43]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
- Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943 [Baseline through final follow-up at approximately Day 43]
Pharmacokinetics: AUC(0-inf) of LY3437943
- Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943 [Baseline through final follow-up at approximately Day 43]
Pharmacokinetics: Cmax of LY3437943
- Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943 [Baseline through final follow-up at approximately Day 43]
Pharmacokinetics: Tmax of LY3437943
Eligibility Criteria
Criteria
Inclusion Criteria:
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Overtly healthy male or a female who cannot get pregnant
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Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
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Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
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Have veins suitable for ease of blood sampling
Exclusion Criteria:
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Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
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Have previously completed or withdrawn from this study
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Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
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Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
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Have been treated with weight loss medications within 3 months of screening
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Lilly Centre for Clinical Pharmacology | Singapore | Singapore | 138623 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17136
- J1I-MC-GZBA