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Trial · NCT04441931

A Study of LY3832479 (LY-CoV016) in Healthy Participants

NCT04441931, Phase 1, Completed, Eli Lilly and Company; results first posted 2021-12-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of LY3832479 (LY-CoV016) in Healthy Participants. Trials, record NCT04441931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04441931

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study of LY3832479 (LY-CoV016) in Healthy Participants
NCT number
NCT04441931
Status
Completed
Phases
Phase 1
Enrollment
26 participants, actual
Lead sponsor
Eli Lilly and Company
Conditions
Healthy
Interventions
LY3832479, Placebo
First posted
2020-06-22
Last updated
2021-12-06
Results first posted
2021-12-06

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study DrugBaseline through Follow-up (Week 12)
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
SecondaryPharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC\[0-∞\]) of LY3832479.
SecondaryPK: Maximum Serum Concentration (Cmax) of LY3832479Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85PK: Maximum Serum Concentration (Cmax) of LY3832479.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study DrugBaseline through Follow-up (Week 12)All randomized participants who received at least one dose of study drug.ParticipantsNUMBER
SECONDARYPharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85All randomized participants who received at least one dose of study drug and had evaluable PK data.micrograms*day per milliliter(ug*day/mL)GEOMETRIC_MEAN
SECONDARYPK: Maximum Serum Concentration (Cmax) of LY3832479Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85All randomized participants who received at least one dose of study drug and had evaluable PK data.ug/mLGEOMETRIC_MEAN

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study DrugPooled Placebo0Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug700 mg LY3832479 IV0Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug2800 mg LY3832479 IV0Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug7000 mg LY3832479 IV0Participants
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479700 mg LY3832479 IV4920Geometric Coefficient of Variation 23micrograms*day per milliliter(ug*day/mL)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY38324792800 mg LY3832479 IV22700Geometric Coefficient of Variation 22micrograms*day per milliliter(ug*day/mL)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY38324797000 mg LY3832479 IV50800Geometric Coefficient of Variation 33micrograms*day per milliliter(ug*day/mL)
PK: Maximum Serum Concentration (Cmax) of LY3832479700 mg LY3832479 IV244Geometric Coefficient of Variation 24ug/mL
PK: Maximum Serum Concentration (Cmax) of LY38324792800 mg LY3832479 IV1130Geometric Coefficient of Variation 14ug/mL
PK: Maximum Serum Concentration (Cmax) of LY38324797000 mg LY3832479 IV2390Geometric Coefficient of Variation 23ug/mL

Participant flow16

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPooled Placebo6
Overall StudySTARTED700 mg LY3832479 IV7
Overall StudySTARTED2800 mg LY3832479 IV7
Overall StudySTARTED7000 mg LY3832479 IV6
Overall StudyReceived at Least One Dose of Study DrugPooled Placebo6
Overall StudyReceived at Least One Dose of Study Drug700 mg LY3832479 IV7
Overall StudyReceived at Least One Dose of Study Drug2800 mg LY3832479 IV7
Overall StudyReceived at Least One Dose of Study Drug7000 mg LY3832479 IV6
Overall StudyCOMPLETEDPooled Placebo6
Overall StudyCOMPLETED700 mg LY3832479 IV7

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDyspepsiaGastrointestinal disordersPooled Placebo IV161
otherDyspepsiaGastrointestinal disorders700 mg LY3832479 IV070
otherDyspepsiaGastrointestinal disorders2800 mg LY3832479 IV070
otherDyspepsiaGastrointestinal disorders7000 mg LY3832479 IV060
otherCovid-19Infections and infestationsPooled Placebo IV161
otherCovid-19Infections and infestations700 mg LY3832479 IV070
otherCovid-19Infections and infestations2800 mg LY3832479 IV070
otherCovid-19Infections and infestations7000 mg LY3832479 IV060
otherArthropod stingInjury, poisoning and procedural complicationsPooled Placebo IV161
otherArthropod stingInjury, poisoning and procedural complications700 mg LY3832479 IV070

Adverse event totals12

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPooled Placebo IV06
Total, all-cause mortality700 mg LY3832479 IV07
Total, all-cause mortality2800 mg LY3832479 IV07
Total, all-cause mortality7000 mg LY3832479 IV06
Total, other adverse eventsPooled Placebo IV36
Total, other adverse events700 mg LY3832479 IV27
Total, other adverse events2800 mg LY3832479 IV27
Total, other adverse events7000 mg LY3832479 IV06
Total, serious adverse eventsPooled Placebo IV06
Total, serious adverse events700 mg LY3832479 IV07

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
34473343DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04441931

GET https://conductscience.org/api/trials/v1/NCT04441931/events?page=2