HealthyPhase 1NCT04183283

A Study of LY3526318 in Healthy Women

A Phase 1 study testing LY3526318 in people with Healthy, run by Eli Lilly and Company at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main purpose of this study is to learn more about how LY3526318 affects blood flow to the skin in healthy women. For each participant, the study will last up to 28 days and Part B will last up to 78 days, including screening and follow-up. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3526318
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteBelgium
Study dates: 12 Dec 2019to 6 Mar 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Must be healthy female participants as determined by medical history and physical examination
--Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [for example (e.g.) tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months)
Must have a body-mass index of 18 to 30 kilograms per square meter, inclusive
Must be willing to follow specific study procedures including
No drugs (except study drug, hormonal contraceptives) 7 days prior to each assessment and until discharge from Clinical Research Unit (CRU)
No chocolate, alcohol, or caffeine containing products 24 hours prior to initiation of each assessment and until discharge
A complete 4 hour fast (water is allowed) prior to cinnamaldehyde (CA) assessment
Must have suitable skin characteristics for the dermal CA challenge procedures and measured through Laser Doppler Imaging (LDI)

Who cannot join

Must not be currently enrolled in or discontinued within the last 30 days or 5 half-lives of the study drug (whichever is longer), from a clinical study involving an investigational product or any type of medical research judged not compatible with this study
Must not have received treatment with biological agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Must not have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality that would preclude study participation
Must not have an abnormality in the 12-lead electrocardiogram (ECG) or confirmed Frederica's corrected QT interval greater than (>) 470 millisecond (msec)
Must not have a history of clinically significant multiple or severe drug allergies or severe post-treatment hypersensitivity reactions
Must avoid excessive tanning

Show all 10Show fewer

Must not use lotions, oils, depilatory preparations, makeup, or other topical treatments on the arms on a regular basis or have used any topical treatments within 7 days prior to start of the first study day
Must not be a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee, or cola drinks/day) or who cannot refrain from caffeinated beverages 24 hours prior to CA application
Must not be drinking alcohol 24 hours prior to each assessment
Must not be around second-hand smoke 24 hours prior to CA application or use nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000

Other trials in Belgium

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Oral Single-Doses of LY3526318 on Cinnamaldehyde-Induced Dermal Blood Flow in Healthy Females

Conditions: Healthy
Being tested: LY3526318, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3526318Drug
Administered orally.
PlaceboDrug
Administered orally.

Study groups in NCT04183283
Study group	Role	What they receive
LY3526318	Experimental	10 milligrams (mg), 30 mg and 100 mg LY3526318 administered orally in three of four study periods. Receives: Drug: LY3526318
Placebo	Placebo comparator	Placebo administered orally in one of four study periods. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
CA-induced DBF was measured by laser doppler imaging (LDI). Least Squares (LS) mean was determined by analysis of variance (ANOVA) model with treatment, period, sequence, time and treatment*time interaction as fixed factors and subject within sequence as a random factor.
Measured: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)

Secondary outcomes (4)

Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
CA-induced DBF was measured by LSCI. LS mean was determined by ANOVA model with treatment, period, sequence, time and treatment*time interaction as fixed factors and subject within sequence as a random factor.
Measured: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
Measured: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Measured: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)
Plasma Concentrations of LY3526318 at 3 and 24 Hours
Plasma Concentrations of LY3526318 at 3 and 24 Hours
Measured: 3 hours and 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 20196 Mar 2020

First posted3 Dec 2019
Study start12 Dec 2019
Primary completion28 Feb 2020
Study completion6 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04183283
Sponsor's protocol ID: 17482
Other IDs: J2D-MC-CVAB, 2019-003613-34, 2019
Status last verified: Sep 2025
First submitted: 29 Nov 2019
Last updated: 6 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Oral Single-Doses of LY3526318 on Cinnamaldehyde-Induced Dermal Blood Flow in Healthy Females
ClinicalTrials.gov ID: NCT04183283
Acronym / sponsor ID: 17482
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 12 Dec 2019 (actual)
Primary completion: 28 Feb 2020 (actual)
Study completion: 6 Mar 2020 (actual)
First posted: 3 Dec 2019 (actual)
Results: Posted 6 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LY3526318	Experimental	Drug: LY352631810 milligrams (mg), 30 mg and 100 mg LY3526318 administered orally in three of four study periods.
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered orally in one of four study periods.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Must be healthy female participants as determined by medical history and physical examination
--Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [for example (e.g.) tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months)
Must have a body-mass index of 18 to 30 kilograms per square meter, inclusive
Must be willing to follow specific study procedures including
Must have suitable skin characteristics for the dermal CA challenge procedures and measured through Laser Doppler Imaging (LDI)

Key exclusion criteria (10 listed)

Must not be currently enrolled in or discontinued within the last 30 days or 5 half-lives of the study drug (whichever is longer), from a clinical study involving an investigational product or any type of medical research judged not compatible with this study
Must not have received treatment with biological agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Must not have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality that would preclude study participation
Must not have an abnormality in the 12-lead electrocardiogram (ECG) or confirmed Frederica's corrected QT interval greater than (>) 470 millisecond (msec)
Must not have a history of clinically significant multiple or severe drug allergies or severe post-treatment hypersensitivity reactions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3526318Administered orally.	Drug	LY3526318
PlaceboAdministered orally.	Drug	Placebo

Primary outcome

Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
Time frame: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)
CA-induced DBF was measured by laser doppler imaging (LDI). Least Squares (LS) mean was determined by analysis of variance (ANOVA) model with treatment, period, sequence, time and treatment*time interaction as fixed factors and subject within sequence as a random factor.

4 secondary outcomes

Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
Time frame: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
Time frame: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)
Plasma Concentrations of LY3526318 at 3 and 24 Hours
Time frame: 3 hours and 24 hours post dose

Results and safety

Results posted to the registry on 6 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Placebo,10 mg LY3526318,100 mg LY3526318,30 mg LY3526318	4	4
Sequence 2: 10 mg LY3526318,30 mg LY3526318, Placebo,100 mg LY3526318	4	3
Sequence 3: 30 mg LY3526318,100 mg LY3526318,10 mg LY3526318, Placebo	4	4
Sequence 4: 100 mg LY3526318, Placebo, 30 mg LY3526318,10 mg LY3526318	4	4

Primary outcome: Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)

Time frame: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge). Least squares mean (Standard Error). Unit: Perfusion unit

Measure	Placebo n = 14	10 mg LY3526318 n = 16	30 mg LY3526318 n = 15	100 mg LY3526318 n = 15
Ring/CA Concentration (conc): Vehicle, Type: Region of Interest (ROI)	-9.46 (6.45)	-6.96 (6.45)	-14.82 (6.45)	-7.78 (6.45)
Ring/CA conc: Vehicle, Type: Entire Image	-14.22 (3.28)	-15.1 (3.28)	-12.34 (3.28)	-13.57 (3.28)
Ring/CA conc: 3%, Type: Region of Interest) ROI	811.66 (98.22)	757.83 (98.22)	771.15 (98.22)	758.66 (98.22)
Ring/CA conc: 3%, Type: Entire Image	213.82 (37.75)	177.17 (37.75)	191.32 (37.75)	179.95 (37.75)
Ring/CA conc: 10% , Type: Region of Interest (ROI)	1264.46 (88.61)	1233.80 (88.61)	1165.69 (88.61)	1049.57 (88.61)
Ring/CA conc: 10% , Type: Entire Image	610.17 (65.79)	606.28 (65.79)	419.15 (65.79)	357.93 (65.79)

Placebo vs 10 mg LY3526318: Mean Difference (Final Values): 2.49 (90% CI -10.66 to 15.65), p = 0.75, ANOVA
Placebo vs 30 mg LY3526318: Mean Difference (Final Values): -5.37 (90% CI -18.49 to 7.76), p = 0.50, ANOVA
Placebo vs 100 mg LY3526318: Mean Difference (Final Values): 1.68 (90% CI -11.48 to 14.84), p = 0.83, ANOVA

Population analysed: All participants who received LY3526318 or placebo at least once and had at least one reliable post-dose pharmacodynamic measurement.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up To 50 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 14 (0%)	11 of 14 (78.6%)	0 of 14
LY3526318 10 mg	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16
LY3526318 30 mg	0 of 15 (0%)	5 of 15 (33.3%)	0 of 15
LY3526318 100 mg	0 of 15 (0%)	5 of 15 (33.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3526318 in people with Healthy, run by Eli Lilly and Company at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI) (time frame: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04183283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.