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CompletedNCT04991766Updated Dec 5, 2025Results posted

A Study of [¹⁴C]-LY3484356 in Healthy Female Participants

A Phase 1 interventional study of [¹⁴C]-LY3484356 and LY3484356 in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.

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

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

02

Conditions studied

  • Healthy

Keywords

  • Metabolism
  • Absolute Bioavailability
  • Disposition
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.

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

Browse Eli Lilly and Company studies →

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal.
  • Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)

Exclusion criteria

Exclusion Criteria:

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders
  • Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    [¹⁴C]-LY3484356 (Part 1)

    Participants received a single oral dose of 400 mg Carbon 14 labelled \[¹⁴C\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.

    Drug: [¹⁴C]-LY3484356

  • Experimental
    LY3484356 + [¹⁴C]-LY3484356 (Part 2)

    Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 microgram (μg) \[¹⁴C\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1.

    Drug: LY3484356 · Drug: [¹⁴C]-LY3484356 (IV)

Interventions

  • Drug[¹⁴C]-LY3484356

    Administered orally.

  • DrugLY3484356

    Administered orally.

  • Drug[¹⁴C]-LY3484356 (IV)

    Administered IV.

06

What researchers measure

Primary outcomes

  1. Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) \* 100.

    Time frame: Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose

  2. Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) \* 100.

    Time frame: Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose

  3. Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356

    PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as "F %= \[AUC (0-∞), LY3484356\] × \[Dose, \[14C\]-LY3484356\] / \[AUC (0-∞), \[14C\]-LY3484356\] × \[Dose, LY3484356\] ×100%'' Higher percent indicates better absorption of drug into the body.

    Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose

Secondary outcomes

  1. Part 1: PK: Total Radioactivity Recovered in Urine, Feces

    Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine/Feces=\[(percentage of radioactivity in peak)/100\]\*(percentage of dose in sample).

    Time frame: Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose

  2. Part 1: Total Radioactivity Recovered in Expired Air

    Radioactivity is expressed in becquerels (Bq), the International System of Unit (SI) representing one nuclear disintegration per second. For practical measurement, total radioactivity recovered in expired air is reported in disintegrations per minute (dpm). The conversion factor is: 1 Bq = 60 dpm.

    Time frame: predose, 8, and 24 hours postdose

  3. Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces

    Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency.

    Time frame: Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose

  4. Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma

    PK: AUC \[0-∞\] of LY3484356 in Plasma.

    Time frame: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose

  5. Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma

    PK: AUC \[0-∞\] of Plasma Total Radioactivity. Total radioactivity is reported as nanogram\* hours equivalents per milliliter (ng\*h Eq/mL).

    Time frame: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose

  6. Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma

    PK: Cmax for LY3484356 in plasma.

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose

  7. Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma

    PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL).

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose

  8. Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma

    PK: AUC \[0-∞\] of Total Radioactivity. Total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL).

    Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose

  9. Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma

    PK: AUC \[0-∞\] of Total Radioactivity in Plasma.

    Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose

  10. Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma

    PK: Cmax of LY3484356 and \[¹⁴C\]-LY3484356 in plasma.

    Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose

  11. Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma

    PK: Cmax of total radioactivity in plasma.

    Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose

07

Results

Posted Dec 5, 2025

Participant flow

Participant flow — Overall Study
MilestonePart 1: [¹⁴C]-LY3484356Part 2: LY3484356 + [¹⁴C] LY3484356
Started88
Received at least 1 dose of study drug88
Completed68
Not completed20
Withdrew: Withdrawal by subject20

Outcome measures

PrimaryPart 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) \* 100.

Time frame:
Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose
Reported as:
Mean · percentage of the total radioactive dose
Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
percentage of the total radioactive dosePart 1: [¹⁴C]-LY3484356
Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered97.3 (90.0 to 101.0)
PrimaryPart 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) \* 100.

Time frame:
Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose
Reported as:
Mean · percentage of the total radioactive dose
Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
percentage of the total radioactive dosePart 1: [¹⁴C]-LY3484356
Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered0.278 (0.109 to 0.497)
PrimaryPart 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356

PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as "F %= \[AUC (0-∞), LY3484356\] × \[Dose, \[14C\]-LY3484356\] / \[AUC (0-∞), \[14C\]-LY3484356\] × \[Dose, LY3484356\] ×100%'' Higher percent indicates better absorption of drug into the body.

Time frame:
Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Reported as:
Geometric mean · percent absolute bioavailability
Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356
percent absolute bioavailabilityPart 2: LY3484356 + [¹⁴C]-LY3484356
Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY348435610.5 ± 32
SecondaryPart 1: PK: Total Radioactivity Recovered in Urine, Feces

Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine/Feces=\[(percentage of radioactivity in peak)/100\]\*(percentage of dose in sample).

Time frame:
Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose
Reported as:
Mean · percentage of recovered radioactivity
Part 1: PK: Total Radioactivity Recovered in Urine, Feces
percentage of recovered radioactivityPart 1: [¹⁴C]-LY3484356
Urine Radioactivity0.278 (0.109 to 0.497)
Fecal Radioactivity97.3 (90.0 to 101.0)
SecondaryPart 1: Total Radioactivity Recovered in Expired Air

Radioactivity is expressed in becquerels (Bq), the International System of Unit (SI) representing one nuclear disintegration per second. For practical measurement, total radioactivity recovered in expired air is reported in disintegrations per minute (dpm). The conversion factor is: 1 Bq = 60 dpm.

Time frame:
predose, 8, and 24 hours postdose
Reported as:
Number · disintegrations per minute
Part 1: Total Radioactivity Recovered in Expired Air
disintegrations per minutePart 1: [¹⁴C]-LY3484356
8 hours postdose53
24 hours postdose62
SecondaryPart 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces

Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency.

Time frame:
Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose
Reported as:
Number · number of metabolites
Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces
number of metabolitesPart 1: [¹⁴C]-LY3484356
Plasma3
Urine0
Feces7
SecondaryPart 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma

PK: AUC \[0-∞\] of LY3484356 in Plasma.

Time frame:
Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Reported as:
Geometric mean · nanogram*hour per milliliter (ng*hr/mL)
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma
nanogram*hour per milliliter (ng*hr/mL)Part 1: [¹⁴C]-LY3484356
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma3130 ± 38
SecondaryPart 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma

PK: AUC \[0-∞\] of Plasma Total Radioactivity. Total radioactivity is reported as nanogram\* hours equivalents per milliliter (ng\*h Eq/mL).

Time frame:
Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Reported as:
Geometric mean · ng*h Eq/mL
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
ng*h Eq/mLPart 1: [¹⁴C]-LY3484356
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma17900 ± 39
SecondaryPart 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma

PK: Cmax for LY3484356 in plasma.

Time frame:
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma
nanogram per milliliter (ng/mL)Part 1: [¹⁴C]-LY3484356
Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma108 ± 48
SecondaryPart 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma

PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL).

Time frame:
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Reported as:
Geometric mean · ng Eq/mL
Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
ng Eq/mLPart 1: [¹⁴C]-LY3484356
Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma537 ± 18
SecondaryPart 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma

PK: AUC \[0-∞\] of Total Radioactivity. Total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL).

Time frame:
Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Reported as:
Geometric mean · ng*hr/mL
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
ng*hr/mLPart 2: LY3484356 + [¹⁴C]-LY3484356
Plasma [14C]-LY34843561.95 ± 26
Plasma LY34843561810 ± 45
SecondaryPart 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma

PK: AUC \[0-∞\] of Total Radioactivity in Plasma.

Time frame:
Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Reported as:
Geometric mean · ng*h Eq/mL
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
ng*h Eq/mLPart 2: LY3484356 + [¹⁴C]-LY3484356
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma7.44 ± 18
SecondaryPart 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma

PK: Cmax of LY3484356 and \[¹⁴C\]-LY3484356 in plasma.

Time frame:
Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Reported as:
Geometric mean · ng/mL
Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
ng/mLPart 2: LY3484356 + [¹⁴C]-LY3484356
Plasma [14C]-LY34843560.575 ± 21
Plasma LY348435633.1 ± 59
SecondaryPart 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma

PK: Cmax of total radioactivity in plasma.

Time frame:
Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Reported as:
Geometric mean · ng Eq/mL
Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
ng Eq/mLPart 2: LY3484356 + [¹⁴C]-LY3484356
Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma0.857 ± 18

Adverse events

Collected over Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part 1: [¹⁴C]-LY34843560/8 (0%)0/8 (0%)8/8 (100%)
Part 2: LY3484356 + [¹⁴C]-LY34843560/8 (0%)0/8 (0%)3/8 (37.5%)
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPart 1: [¹⁴C]-LY3484356Part 2: LY3484356 + [¹⁴C]-LY3484356
DiarrhoeaGastrointestinal disorders3/80/8
NauseaGastrointestinal disorders2/81/8
VomitingGastrointestinal disorders2/80/8
Supraventricular extrasystolesCardiac disorders0/81/8
Abdominal pain lowerGastrointestinal disorders1/80/8
Abdominal pain upperGastrointestinal disorders1/80/8
ConstipationGastrointestinal disorders1/80/8
HaematocheziaGastrointestinal disorders1/80/8
Infusion site painGeneral disorders0/81/8
PyuriaInfections and infestations1/80/8

Baseline characteristics

All enrolled participants who received at least 1 dose of study drug (LY3484356 or \[¹⁴C\]-LY3484356).

Age, Continuous
Age, Continuous(years)Part 1: [¹⁴C]-LY3484356Part 2: LY3484356 + [¹⁴C] LY3484356Total
Mean52.8 ± 7.153.3 ± 9.453.0 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)Part 1: [¹⁴C]-LY3484356Part 2: LY3484356 + [¹⁴C] LY3484356Total
Female8816
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part 1: [¹⁴C]-LY3484356Part 2: LY3484356 + [¹⁴C] LY3484356Total
Hispanic or Latino213
Not Hispanic or Latino6713
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Part 1: [¹⁴C]-LY3484356Part 2: LY3484356 + [¹⁴C] LY3484356Total
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American325
White358
More than one race112
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Part 1: [¹⁴C]-LY3484356Part 2: LY3484356 + [¹⁴C] LY3484356Total
United States8816
08

Study locations

1 site
  • LabCorp CRU, Inc.
    Madison, Wisconsin 53704, United States
09

References and documents

Study documents

  • Study protocol · Aug 5, 2021
  • Statistical analysis plan · Jul 21, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04991766
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 5, 2021
Start date
Aug 13, 2021
Primary completion
Apr 2, 2022
Completion
Apr 2, 2022
Results posted
Dec 5, 2025
Last update
Dec 5, 2025

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
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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