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CompletedNCT03083561Updated Aug 25, 2023Results posted

A Study of LY3337641 in Japanese and Caucasian Healthy Participants

A Phase 1 interventional study of LY3337641 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-25.

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

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study summary

The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in healthy Japanese and Caucasian participants. The study will also investigate how the body processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4 weeks for each participant. Screening may occur within 28 days prior to first dose of study drug.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) 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
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Overtly healthy Japanese or Caucasian
  • Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

Exclusion criteria

Exclusion Criteria:

  • Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
  • 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 or affects or confounds the QTc analysis or have Fridericia-corrected QT interval (QTcF) >450 milliseconds (msec) for males and >470 msec for females
  • Have had symptomatic herpes zoster within 3 months of screening
  • Have active or latent tuberculosis (TB) based on a positive medical history, examination, and/or TB test results.
  • Have received live vaccine(s) within 1 month of screening or intend to during the study
  • Are immunocompromised
  • Have a history of constipation or have had acute constipation within 3 weeks prior to admission
05

Study design

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

Study arms

  • Experimental
    LY3337641 Multiple Dose

    Multiple doses of 30 mg LY3337641 tablet administered orally every day for two weeks, with a two week follow-up period.

    Drug: LY3337641

  • Placebo comparator
    Placebo Multiple Dose

    Multiple doses of placebo administered orally every day for two weeks, with a two week follow-up period.

    Drug: Placebo

  • Experimental
    LY3337641 Single Dose

    Single dose of 5 mg, 80 mg and 160 mg LY3337641 tablet administered orally, with a two week follow-up period.

    Drug: LY3337641

  • Placebo comparator
    Placebo Single Dose

    Single dose of placebo administered orally, with a two week follow-up period.

    Drug: Placebo

Interventions

  • DrugLY3337641

    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

    Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

    Time frame: Up To 31 Days

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641

    Cmax of LY3337641 was evaluated.

    Time frame: MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose

  2. PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641

    AUC from zero to 24-hour of LY3337641 was evaluated.

    Time frame: MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose

  3. PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641

    AUC from zero to infinity of LY3337641 was evaluated. For 30mg LY3337641 MD Day 1, pharmacokinetic data up to 24-hour post-dose were used for pharmacokinetic parameters calculation.

    Time frame: MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose

07

Results

Posted Aug 25, 2023

Participant flow

Participant flow — Overall Study
MilestonePlacebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MD
Started666639
Received at least 1 dose of study drug666639
Completed666639
Not completed000000

Outcome measures

PrimaryNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame:
Up To 31 Days
Reported as:
Count of participants · Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
ParticipantsPlacebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MD
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration000000
SecondaryPharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641

Cmax of LY3337641 was evaluated.

Time frame:
MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641
nanogram per milliliter (ng/mL)5mg LY3337641 SD30mg LY3337641 MD Day 180mg LY3337641 SD160mg LY3337641 SD30mg LY3337641 MD Day 15
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY333764111.5 ± 5656.5 ± 44186 ± 25358 ± 3765.8 ± 54
SecondaryPK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641

AUC from zero to 24-hour of LY3337641 was evaluated.

Time frame:
MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose
Reported as:
Geometric mean · nanogram*hour per milliliter (ng*hr/mL)
PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641
nanogram*hour per milliliter (ng*hr/mL)5mg LY3337641 SD30mg LY3337641 MD Day 180mg LY3337641 SD160mg LY3337641 SD30mg LY3337641 MD Day 15
PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY333764184.8 ± 58276 ± 591040 ± 262100 ± 47368 ± 65
SecondaryPK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641

AUC from zero to infinity of LY3337641 was evaluated. For 30mg LY3337641 MD Day 1, pharmacokinetic data up to 24-hour post-dose were used for pharmacokinetic parameters calculation.

Time frame:
MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose
Reported as:
Geometric mean · ng*hr/mL
PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
ng*hr/mL5mg LY3337641 SD30mg LY3337641 MD Day 180mg LY3337641 SD160mg LY3337641 SD30mg LY3337641 MD Day 15
PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY333764192.0 ± 62283 ± 611060 ± 272150 ± 48382 ± 68

Adverse events

Collected over Up To 31 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo SD0/6 (0%)0/6 (0%)1/6 (16.7%)
5 mg LY3337641 SD0/6 (0%)0/6 (0%)0/6 (0%)
80 mg LY3337641 SD0/6 (0%)0/6 (0%)1/6 (16.7%)
160 mg LY3337641 SD0/6 (0%)0/6 (0%)2/6 (33.3%)
Placebo MD0/3 (0%)0/3 (0%)3/3 (100%)
30 mg LY3337641 MD0/9 (0%)0/9 (0%)6/9 (66.7%)
Most frequent other events
Showing 10 of 22
Most frequent other events
EventPlacebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MD
ConstipationGastrointestinal disorders0/60/60/60/62/35/9
Abdominal pain upperGastrointestinal disorders0/60/60/60/61/30/9
DiarrhoeaGastrointestinal disorders0/60/60/60/61/31/9
Dry mouthGastrointestinal disorders0/60/60/60/61/31/9
Vessel puncture site haemorrhageGeneral disorders0/60/60/60/61/30/9
HeadacheNervous system disorders1/60/60/60/61/31/9
AcneSkin and subcutaneous tissue disorders0/60/60/60/61/30/9
Rash maculo-papularSkin and subcutaneous tissue disorders0/60/60/60/61/31/9
UrticariaSkin and subcutaneous tissue disorders0/60/60/60/61/30/9
FatigueGeneral disorders1/60/60/60/60/30/9

Baseline characteristics

All enrolled participants.

Age, Continuous
Age, Continuous(years)Placebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MDTotal
Mean42.2 ± 11.544.5 ± 10.146.7 ± 11.645.5 ± 12.036.0 ± 8.940.8 ± 12.543.0 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Placebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MDTotal
Female22242315
Male44421621
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MDTotal
Hispanic or Latino0000101
Not Hispanic or Latino66662935
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MDTotal
American Indian or Alaska Native0000000
Asian33332620
Native Hawaiian or Other Pacific Islander0000000
Black or African American0000000
White33331316
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(Participants)Placebo SD5 mg LY3337641 SD80 mg LY3337641 SD160 mg LY3337641 SDPlacebo MD30 mg LY3337641 MDTotal
United States66663936
08

Study locations

1 site
  • WCCT Global
    Cypress, California 90630, United States
09

References and documents

Study documents

  • Study protocol · Mar 16, 2017
  • Statistical analysis plan · Mar 24, 2017

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

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in May 2017, 2 months.

Results were first posted in Aug 2023, 6 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2017
First posted
Mar 20, 2017
StartActual
Mar 15, 2017
Primary completionActual
May 25, 2017
CompletionActual
May 25, 2017
Results first posted
Aug 25, 2023
Last update
Aug 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03083561
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Mar 20, 2017
Start date
Mar 15, 2017
Primary completion
May 25, 2017
Completion
May 25, 2017
Results posted
Aug 25, 2023
Last update
Aug 25, 2023

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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