CClinicalTrials.gg
CompletedNCT04472676Updated Dec 14, 2021

A Study of LY3473329 in Healthy Participants

A Phase 1 interventional study of LY3473329 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 54 Years
Sex
All
01

Study summary

The main purpose of this study in healthy participants is to learn more about the safety of LY3473329 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3473329 gets into the bloodstream and how long the body takes to eliminate it. This is a two-part study. Participants may only enroll in one part.

For each participant:

  • Part A will last up to about 19 weeks and may include 9 visits.
  • Part B will last up to about 28 weeks and may include 11 visits.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males and females must adhere to contraception restrictions
  • Have clinical laboratory test results within normal reference range or with acceptable deviations
  • Body mass index (BMI) less than or equal to (≤)30 kilograms per square meter (kg/m²)
  • For Part B:

    • Lipoprotein (a) (Lp[a]) greater than or equal to (≥)75 nanomoles per Liter (nmol/L) or 30 milligrams per deciliter (mg/dL) at screening
    • Plasminogen is within the normal range at screening

Exclusion criteria

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the past 30 days from, a clinical trial involving an investigational drug that has not received regulatory approval for any indication, except for any trial involving antisense Lp(a), for which 6 months must have passed from the participant's last study drug dose
  • Have previously completed or withdrawn from this study or any other study investigating LY3473329
  • Are pregnant or breast feeding
  • Glomerular filtration rate (GFR) is lower than estimated GFR 60 milliliters per minute per 1.73 square meters (mL/min/1.73 m2) using the Modification of Diet in Renal Disease Study equation
  • Have a history or presence of medical illness including, but not limited to, any cardiovascular, thromboembolism or bleeding disorder, hepatic, respiratory, hematological, endocrine, immune, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study. In addition, participants with the following findings will be excluded: Confirmed Fridericia's corrected QT interval greater than (>)450 milliseconds (msec) for men and >470 msec for women. One additional ECG may be performed if required
  • Have an elevated high-sensitivity C-reactive protein (>3 milligrams per Liter [mg/L]) or have a prothrombin time/international normalized ratio (PT/INR) or activated partial thromboplastin time (aPTT) >1.25 times (x) upper limit of normal (ULN)
  • Are an investigator or site personnel directly affiliated or immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted
  • Are Lilly employees or contractors or an immediate family member of such
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen
  • Have donated more than 500 milliliters (mL) of blood within the past month
  • Are unwilling to stop alcohol consumption while resident in the clinical research unit (CRU)
  • Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Have an abnormal blood pressure (supine) defined as diastolic blood pressure >95 or less than (\<)45 millimeters of Mercury (mmHg) and/or systolic blood pressure >160 or \<90 mmHg. Re-testing may occur once during screening within 2 hours of the initial abnormal blood pressure measurement at the discretion of the investigator at screening
  • Have positive findings for known drugs of abuse on urinary drug screening
  • Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus nasopharyngeal polymerase chain reaction (PCR) test at Day -1
  • Contact with SARS-CoV-2- positive or corona virus disease 2019 (COVID-19) patient within the last 14 days prior to admission to the clinical unit
  • In the opinion of the investigator or the sponsor, are unsuitable for inclusion in the study
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    LY3473329 (Part A)

    LY3473329 administered orally.

    Drug: LY3473329

  • Placebo comparator
    Placebo (Part A)

    Placebo administered orally.

    Drug: Placebo

  • Experimental
    LY3473329 (Part B)

    LY3473329 administered orally.

    Drug: LY3473329

  • Experimental
    Placebo (Part B)

    Placebo administered orally.

    Drug: Placebo

Interventions

  • DrugLY3473329

    Administered orally.

  • DrugPlacebo

    Administered orally.

06

What researchers measure

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Time frame: Baseline up to Day 137

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329

    PK: AUC of LY3473329

    Time frame: Baseline up to Day 137

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3473329

    PK: Cmax of LY3473329

    Time frame: Baseline up to Day 137

07

Study locations

1 site
  • PRA Health Sciences
    Groningen, 9728, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04472676
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jul 15, 2020
Start date
Aug 18, 2020
Primary completion
Nov 9, 2021
Completion
Nov 9, 2021
Last update
Dec 14, 2021

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion