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A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3437943 in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03841630
Enrollment
45
Registered
2019-02-15
Start date
2019-03-13
Completion date
2019-07-25
Last updated
2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

Administered subcutaneously (SC)

DRUGPlacebo

Administered SC

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Overtly healthy male or a female who cannot get pregnant * Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study * Have veins suitable for ease of blood sampling

Exclusion criteria

* 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30 days or any other type of medical research judged to be incompatible with this study * Have previously completed or withdrawn from this study * Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study * Have or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 * Have been treated with weight loss medications within 3 months of screening

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationBaseline through final follow-up at approximately Day 43A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary

MeasureTime frameDescription
Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943Baseline through final follow-up at approximately Day 43Pharmacokinetics: AUC(0-inf) of LY3437943
Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943Baseline through final follow-up at approximately Day 43Pharmacokinetics: Cmax of LY3437943
Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943Baseline through final follow-up at approximately Day 43Pharmacokinetics: Tmax of LY3437943

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026