NCT04586920 is a Phase 1 clinical trial of LY3509754 in Healthy, sponsored by Eli Lilly and Company.

Who is sponsoring NCT04586920?

NCT04586920 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT04586920?

Interventions in NCT04586920: LY3509754, Placebo, Itraconazole, Midazolam.

Is NCT04586920 still recruiting?

NCT04586920 is currently terminated. Last updated 3 January 2025.

Are results published for NCT04586920?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-03 · How we verify

NCT04586920

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

Terminated Phase 1 Results posted Last updated 3 January 2025

What this trial tests

Phase 1 trial testing LY3509754 in Healthy in 104 participants. Terminated before completion.

Timeline

20 October 2020

Primary endpoint
14 October 2022

14 October 2022

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	basic science
Enrollment	104
Start date	20 October 2020
Primary completion	14 October 2022
Estimated completion	14 October 2022
Sites	2 locations across United States

Drugs / interventions tested

LY3509754 — full drug profile →
Placebo
Itraconazole — full drug profile →
Midazolam (midazolam) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Primary · Baseline up to Day 26

An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigat

Group	Value	95% CI
Part A - Placebo (Fasted)	0
Part A - Placebo (Fed)	0
Part A - 10 Milligram (mg) LY3509754 (Fasted)	0
Part A - 30 mg LY3509754 (Fasted)	0
Part A - 100 mg LY3509754 (Fasted)	0
Part A - 300 mg LY3509754 (Fasted)	0
Part A - 300 mg LY3509754 (Fed)	0
Part A - 1000 mg LY3509754 (Fasted)	0
Part A - 2000 mg LY3509754 (Fasted)	0
Part B - Placebo Alone (Day 1)	0
Part B - Placebo + 200 mg Itraconazole (Day 10)	0
Part B - 200 mg Itraconazole (Days 4 to 13)	0

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B Secondary · Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose.

PK: Cmax of LY3509754 in Parts A and B.

Group	Value	95% CI
Part A - 10 mg LY3509754 (Fasted)	20.4	± 28
Part A - 30 mg LY3509754 (Fasted)	49.0	± 26
Part A - 100 mg LY3509754 (Fasted)	136	± 73
Part A - 300 mg LY3509754 (Fasted)	384	± 62
Part A - 300 mg LY3509754 (Fed)	278	± 72
Part A - 1000 mg LY3509754 (Fasted)	1390	± 55
Part A - 2000 mg LY3509754 (Fasted)	2310	± 13
Part B - 10 mg LY3509754 Alone (Day 1)	15.7	± 24
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)	43.3	± 41

PK: Cmax of LY3509754 in Parts C and D Secondary · Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose.

PK: Cmax of LY3509754 in Parts C and D.

Group	Value	95% CI
Part C - 100 mg LY3509754 QD [Cohort 1]	218	± 52
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]	458	± 50
Part C - 1000 mg LY3509754 QD [Cohort 3]	1160	± 55
Part D (Japanese) - 400 mg LY3509754 QD	805	± 30
Part D(Japanese) - 1000 mg LY3509754 QD	2050	± 31

PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B Secondary · Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose.

PK: AUC(0-24) of LY3509754 in Parts A and B.

Group	Value	95% CI
Part A - 10 mg LY3509754 (Fasted)	153	± 20
Part A - 30 mg LY3509754 (Fasted)	375	± 25
Part A - 100 mg LY3509754 (Fasted)	1340	± 60
Part A - 300 mg LY3509754 (Fasted)	3930	± 45
Part A - 300 mg LY3509754 (Fed)	2930	± 69
Part A - 1000 mg LY3509754 (Fasted)	14900	± 42
Part A - 2000 mg LY3509754 (Fasted)	26300	± 29
Part B - 10 mg LY3509754 Alone (Day 1)	135	± 29
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)	596	± 33

PK: AUC(0-24) of LY3509754 in Parts C and D Secondary · Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose.

PK: AUC(0-24) of LY3509754 in Parts C and D.

Group	Value	95% CI
Part C - 100 mg LY3509754 QD [Cohort 1]	2170	± 41
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]	4050	± 38
Part C - 1000 mg LY3509754 QD [Cohort 3]	12200	± 42
Part D (Japanese) - 400 mg LY3509754 QD	7560	± 30
Part D (Japanese) - 1000 mg LY3509754 QD	18000	± 22

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to Up To Day 26. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A - Placebo (Fasted)

Serious: 0/10 (0%)

Deaths: 0/10

Part A - Placebo (Fed)

Serious: 0/2 (0%)

Deaths: 0/2

Part A - 10 Milligram (mg) LY3509754 (Fasted)

Serious: 0/6 (0%)

Deaths: 0/6

Part A - 30 mg LY3509754 (Fasted)

Serious: 0/6 (0%)

Deaths: 0/6

Part A - 100 mg LY3509754 (Fasted)

Serious: 0/6 (0%)

Deaths: 0/6

Part A - 300 mg LY3509754 (Fasted)

Serious: 0/9 (0%)

Deaths: 0/9

Part A - 300 mg LY3509754 (Fed)

Serious: 0/9 (0%)

Deaths: 0/9

Part A - 1000 mg LY3509754 (Fasted)

Serious: 0/6 (0%)

Deaths: 0/6

Part A - 2000 mg LY3509754 (Fasted)

Serious: 0/6 (0%)

Deaths: 0/6

Part B - Placebo Alone (Day 1)

Serious: 0/3 (0%)

Deaths: 0/3

Part B - Placebo + 200 mg Itraconazole (Day 10)

Serious: 0/3 (0%)

Deaths: 0/3

Part B - 200 mg Itraconazole (Days 4 to 13)

Serious: 0/11 (0%)

Deaths: 0/11

Part B - 10 mg LY3509754 Alone (Day 1)

Serious: 0/8 (0%)

Deaths: 0/8

Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)

Serious: 0/8 (0%)

Deaths: 0/8

Part C - Placebo QD [Cohorts 1 and 3]

Serious: 0/4 (0%)

Deaths: 0/4

Part C - 100 mg LY3509754 QD [Cohort 1]

Serious: 0/6 (0%)

Deaths: 0/6

Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]

Serious: 0/10 (0%)

Deaths: 0/10

Part C - Placebo QD (Days 1 to 14) [Cohort 2]

Serious: 0/2 (0%)

Deaths: 0/2

Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]

Serious: 0/8 (0%)

Deaths: 0/8

Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]

Serious: 0/2 (0%)

Deaths: 0/2

Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]

Serious: 0/8 (0%)

Deaths: 0/8

Part C - 1000 mg LY3509754 QD [Cohort 3]

Serious: 0/6 (0%)

Deaths: 0/6

Part D (Japanese) - Placebo QD

Serious: 0/4 (0%)

Deaths: 0/4

Part D (Japanese) - 400 mg LY3509754 QD

Serious: 0/6 (0%)

Deaths: 0/6

Part D (Japanese) - 1000 mg LY3509754 QD

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (31 terms — click to expand)

Reaction	System	Part A - Placebo (Fasted)	Part A - Placebo (Fed)	Part A - 10 Milligram (mg)…	Part A - 30 mg LY3509754 (…	Part A - 100 mg LY3509754 …	Part A - 300 mg LY3509754 …	Part A - 300 mg LY3509754 …	Part A - 1000 mg LY3509754…	Part A - 2000 mg LY3509754…	Part B - Placebo Alone (Da…	Part B - Placebo + 200 mg …	Part B - 200 mg Itraconazo…	Part B - 10 mg LY3509754 A…	Part B - 10 mg LY3509754 +…	Part C - Placebo QD [Cohor…	Part C - 100 mg LY3509754 …	Part C - 1.2 mg Midazolam …	Part C - Placebo QD (Days …	Part C - 300 mg LY3509754 …	Part C - Placebo QD + 1.2 …	Part C - 300 mg LY3509754 …	Part C - 1000 mg LY3509754…	Part D (Japanese) - Placeb…	Part D (Japanese) - 400 mg…	Part D (Japanese) - 1000 m…
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vitreous detachment	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Faeces discoloured	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Saliva altered	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Medical device site irritation	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sensation of foreign body	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vessel puncture site haemorrhage	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gallbladder polyp	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatic steatosis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asymptomatic COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asymptomatic bacteriuria	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatitis e	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gingival injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mouth injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza b virus test positive	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Transaminases increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neuralgia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Choking	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04586920 adverse events section.

Sponsor's own description

The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

New and Emerging Oral/Topical Small-Molecule Treatments for Psoriasis.
Carmona-Rocha E, Rusiñol L, Puig L. · · 2024 · cited 28× · PMID 38399292 · DOI 10.3390/pharmaceutics16020239
Safety, Tolerability, and Pharmacokinetics of an Oral Small Molecule Inhibitor of IL-17A (LY3509754): A Phase I Randomized Placebo-Controlled Study.
Datta-Mannan A, Regev A, Coutant DE, Dropsey AJ, et al · · 2024 · cited 13× · PMID 38294091 · DOI 10.1002/cpt.3185
The Interleukine-17 Cytokine Family: Role in Development and Progression of Spondyloarthritis, Current and Potential Therapeutic Inhibitors.
Davydova A, Kurochkina Y, Goncharova V, Vorobyeva M, et al · · 2023 · cited 10× · PMID 37238999 · DOI 10.3390/biomedicines11051328
Current and Emerging Therapies Targeting the IL-23/IL-17 Axis in Psoriasis.
Han SJ, Jung GY, Lee GC, Ki DH, et al · · 2026 · PMID 42059024 · DOI 10.4062/biomolther.2026.019

Verify or expand the search:

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Other Eli Lilly and Company trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04586920 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 3 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04586920.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04586920

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of LY3509754

Other recruiting trials for Healthy

Other Eli Lilly and Company trials

Verify against primary sources