A Study to Compare Two Formulations of LY3819469 in Healthy Participants

NCT ID: NCT05932446

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2023-11-07

Brief Summary

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The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated.

Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3819469 (Reference)

LY3819469 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3819469

Intervention Type DRUG

Administered SC.

LY3819469 (Test)

LY3819469 administered SC.

Group Type EXPERIMENTAL

LY3819469

Intervention Type DRUG

Administered SC.

Interventions

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LY3819469

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening
* Are male or women not of childbearing potential

Exclusion Criteria

* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data
* Have any abnormality in the 12-lead electrocardiogram (ECG)
* Are heavy alcohol drinkers or heavy cigarette smokers
* Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission
* Have lost or donated blood of more than 450 mililitres (mL) within 3 months
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.

Reference Type DERIVED
PMID: 38682459 (View on PubMed)

Other Identifiers

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J3L-MC-EZEE

Identifier Type: OTHER

Identifier Source: secondary_id

18730

Identifier Type: -

Identifier Source: org_study_id

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