NCT04682119 is a Phase 1 clinical trial of LY3526318 in Healthy, sponsored by Eli Lilly and Company.

Who is sponsoring NCT04682119?

NCT04682119 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT04682119?

Interventions in NCT04682119: LY3526318, Placebo.

Is NCT04682119 still recruiting?

NCT04682119 is currently completed. Last updated 10 September 2025.

Are results published for NCT04682119?

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

Last reviewed 2025-09-10 · How we verify

NCT04682119

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

A Safety Study of LY3526318 in Healthy Participants

Completed Phase 1 Results posted Last updated 10 September 2025

What this trial tests

Phase 1 trial testing LY3526318 in Healthy in 16 participants. Completed in 21 April 2021.

Timeline

29 December 2020

Primary endpoint
21 April 2021

21 April 2021

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	basic science
Enrollment	16
Start date	29 December 2020
Primary completion	21 April 2021
Estimated completion	21 April 2021
Sites	1 location across Netherlands

Drugs / interventions tested

LY3526318 — full drug profile →
Placebo

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.

Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 Primary · Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318

Group	Value	95% CI
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)	147978	± 37.5
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)	131271	± 61.8
Part A - SAD: 250 mg LY3526318 Fasted	137814	± 58.6
Part A - SAD: 100 mg LY3526318 Fasted	76902	± 56.1

Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 Primary · Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

Group	Value	95% CI
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)	12406	± 26.4
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)	6199	± 61.4
Part A - SAD: 250 mg LY3526318 Fasted	9544	± 26.8
Part A - SAD: 100 mg LY3526318 Fasted	5441	± 49.9

Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318 Primary · Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose

Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC\[0-tau \]) of LY3526318

Group	Value	95% CI
Part B MAD:250 mg LY3526318	89614	± 19.7

Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 Primary · Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose

Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

Group	Value	95% CI
Part B MAD:250 mg LY3526318 LY3526318 QD	10717	± 35.1

Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Secondary · Single oral dose to up to 11 days of follow-up

A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.

TEAEs

Group	Value	95% CI
Part A - SAD: Placebo Fasted	2
Part A - SAD: Placebo Fed (Light Breakfast)	1
Part A - SAD: Placebo Fed (High Fat Meal)	1
Part A - SAD: 100 mg LY3526318 Fasted	2
Part A - SAD: 250 mg LY3526318 Fasted	2
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)	4
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)	1

SAEs

Group	Value	95% CI
Part A - SAD: Placebo Fasted	0
Part A - SAD: Placebo Fed (Light Breakfast)	0
Part A - SAD: Placebo Fed (High Fat Meal)	0
Part A - SAD: 100 mg LY3526318 Fasted	0
Part A - SAD: 250 mg LY3526318 Fasted	0
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)	0
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)	0

Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Secondary · Up to 14 days following first dose

TEAEs

Group	Value	95% CI
Part B MAD: Placebo	1
Part B MAD:250 mg LY3526318 LY3526318 QD	4

SAEs

Group	Value	95% CI
Part B MAD: Placebo	0
Part B MAD:250 mg LY3526318 LY3526318 QD	0

Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax) Secondary · Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

Part A, Effect of a meal on pharmacokinetics of LY3526318: Maximum Concentration (Cmax)

Ratio of Fed Light Breakfast/ Fasted

Group	Value	95% CI
Part A: 250 mg LY3526318	1.2768	0.9030 – 1.8052

Ratio of Fed High Fat Meal/ Fasted

Group	Value	95% CI
Part A: 250 mg LY3526318	0.6195	0.4381 – 0.8759

Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) Secondary · Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

Part A, Effect of a meal on pharmacokinetics of LY3526318: Area under the concentration time curve from time 0 to infinity (AUC 0-∞)

Ratio of Fed Light Breakfast/ Fasted

Group	Value	95% CI
Part A: 250 mg LY3526318	1.1341	0.9722 – 1.3229

Ratio of Fed High Fat Meal/ Fasted

Group	Value	95% CI
Part A: 250 mg LY3526318	0.8454	0.7248 – 0.9862

Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax) Secondary · Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)

Fed Light Breakfast - Fasted

Group	Value	95% CI
Part A: 250 mg LY3526318	0.00	0.00 – 2.00

Fed High Fat Meal - Fasted

Group	Value	95% CI
Part A: 250 mg LY3526318	0.03	0.00 – 2.03

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline Up To 14 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A - SAD: Placebo Fed (Light Breakfast)

Serious: 0/2 (0%)

Deaths: 0/2

Part A - SAD: Placebo Fed (High Fat Meal)

Serious: 0/2 (0%)

Deaths: 0/2

Part A - SAD: Placebo Fasted

Serious: 0/4 (0%)

Deaths: 0/4

Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)

Serious: 0/6 (0%)

Deaths: 0/6

Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)

Serious: 0/6 (0%)

Deaths: 0/6

Part A - SAD: 250 mg LY3526318 Fasted

Serious: 0/6 (0%)

Deaths: 0/6

Part A - SAD: 100 mg LY3526318 Fasted

Serious: 0/6 (0%)

Deaths: 0/6

Part B MAD: Placebo

Serious: 0/2 (0%)

Deaths: 0/2

Part B MAD:250 mg LY3526318

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (15 terms — click to expand)

Reaction	System	Part A - SAD: Placebo Fed …	Part A - SAD: Placebo Fed …	Part A - SAD: Placebo Fasted	Part A - SAD: 250 mg LY352…	Part A - SAD: 250 mg LY352…	Part A - SAD: 250 mg LY352…	Part A - SAD: 100 mg LY352…	Part B MAD: Placebo	Part B MAD:250 mg LY3526318
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Catheter site haematoma	General disorders	—	—	—	—	—	—	—	—	—
Catheter site pain	General disorders	—	—	—	—	—	—	—	—	—
Catheter site related reaction	General disorders	—	—	—	—	—	—	—	—	—
Vessel puncture site bruise	General disorders	—	—	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Rash papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04682119 adverse events section.

Sponsor's own description

The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of LY3526318

Trials testing the same drug.

NCT05580250 — A Study of LY3526318 in Healthy Male Japanese Participants · Phase 1 · withdrawn
NCT05177094 — Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain · Phase 2 · completed
NCT05086289 — Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain · Phase 2 · completed
NCT05080660 — Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis · Phase 2 · completed
NCT04183283 — A Study of LY3526318 in Healthy Women · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

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 NCT04682119 (US National Library of Medicine, public domain)
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: 10 September 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/NCT04682119.

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

NCT04682119

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 LY3526318

Other recruiting trials for Healthy

Other Eli Lilly and Company trials

Verify against primary sources