HealthyPhase 1NCT05794243

A Multiple-Dose Study of LY3493269 in Healthy Participants

A Phase 1 study testing LY3493269, Sodium Caprate (C10) and Salcaprozate Sodium (SNAC) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3493269, Sodium Caprate (C10) and Salcaprozate Sodium (SNAC)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteSingapore
Study dates: 23 Mar 2023to 20 Jun 2023
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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female participants who are overtly healthy as determined by medical evaluation
Participants with body mass index (BMI) of 19.0 to 40.0 kilograms per meter squared (kg/m²)
Males who agree to use highly effective/effective methods of contraception and only women not of childbearing potential may participate in the trial

Who cannot join

Have a history of atopy (severe or multiple allergic manifestations) or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis)
Have a significant history of or current cardiovascular (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, gastrointestinal (GI) including involving the liver, gallbladder or gallbladder surgery, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the investigational product (IP); or of interfering with the interpretation of data.
Have a mean supine heart rate (HR) less than 45 bpm or greater than 100 bpm from 2 assessments at screening.
Have a mean supine systolic blood pressure (BP) higher than 160 mmHg and a mean supine diastolic BP higher than 95 mmHg from 2 assessments at screening
Have undergone any form of bariatric surgery.
Have a history of GI bleeding, or gastric or duodenal ulcers.

Show all 18Show fewer

Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the upper limit of normal (ULN).
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
Have evidence of significant active neuropsychiatric disease as determined by the investigator.
Have been treated with prescription drugs that promote weight loss within 3 months prior to screening.
Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study.
Have participated within the past 30 days of screening in a clinical study involving an IP; at least 5 half-lives or 30 days, whichever is longer, should have passed.
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis, such as a QT interval corrected using Fridericia's formula (QTcF) >450 msec for males and >470 msec for females, short PR interval (<120 msec), or PR interval >220 msec, second- or third-degree atrioventricular block, intraventricular conduction delay with QRS >120 msec, right bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome.
Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5x ULN or total bilirubin level (TBL) >1.5x ULN.
Show evidence of human immunodeficiency virus infection and/or positive human immunodeficiency virus antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

Lilly Centre for Clinical Pharmacology
Singapore, 138623

Other trials in Singapore

About this study

Official title: An Open-Label, Multiple-Dose Study to Investigate the Pharmacokinetics of LY3493269 Oral Formulations Administered in a Fed or Fasted State in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3493269 is in the bloodstream and how the body handles and eliminates LY3493269 when administered orally as test compared to reference formulations in healthy participants in fed and/or fasted states. The study will also evaluate the safety and tolerability of LY3493269 in these participants. The study will last up to 43 days excluding the screening period.

Conditions: Healthy
Being tested: LY3493269, Sodium Caprate (C10), Salcaprozate Sodium (SNAC)

What participants receive

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

LY3493269Drug
Administered orally.
Sodium Caprate (C10)Drug
Administered orally.
Salcaprozate Sodium (SNAC)Drug
Administered orally.

Study groups in NCT05794243
Study group	Role	What they receive
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)	Experimental	* Participants were administered oral doses of 4 milligram (mg) LY3493269 test capsule formulation 1, co-administered with 280 mg of sodium caprate (C10). * This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast. Receives: Drug: LY3493269; Drug: Sodium Caprate (C10)
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)	Experimental	* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10. * This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast. Receives: Drug: LY3493269; Drug: Sodium Caprate (C10)
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)	Experimental	* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of salcaprozate sodium (SNAC). * This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast. Receives: Drug: LY3493269; Drug: Salcaprozate Sodium (SNAC)
Part B: LY3493269	Experimental	The formulation of the LY3493269 test capsule (1,2) or reference tablet were planned to be determined based on the initial review of safety and pharmacokinetic data from Part A. Receives: Drug: LY3493269

What is being measured

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

Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269
PK: AUC (0-∞) of LY3493269
Measured: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose
Part A: PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCτ) of LY3493269
PK: AUCτ of LY3493269
Measured: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose
Part A: PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Cmax of LY3493269
Measured: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose

Timeline

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

23 Mar 202320 Jun 2023

First posted3 Apr 2023
Study start23 Mar 2023
Primary completion20 Jun 2023
Study completion20 Jun 2023

Why it stopped: Following preplanned review of the safety and pharmacokinetic data from Part A, it was determined that sufficient data had been obtained. The decision was made to not proceed with Part B and the study was terminated early.

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: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05794243
Sponsor's protocol ID: 18360
Other IDs: J1X-MC-GZHI
Status last verified: Dec 2024
First submitted: 21 Mar 2023
Last updated: 14 Jan 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?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multiple-Dose Study to Investigate the Pharmacokinetics of LY3493269 Oral Formulations Administered in a Fed or Fasted State in Healthy Participants
ClinicalTrials.gov ID: NCT05794243
Acronym / sponsor ID: 18360
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Following preplanned review of the safety and pharmacokinetic data from Part A, it was determined that sufficient data had been obtained. The decision was made to not proceed with Part B and the study was terminated early.
Enrolment: 42 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 23 Mar 2023 (actual)
Primary completion: 20 Jun 2023 (actual)
Study completion: 20 Jun 2023 (actual)
First posted: 3 Apr 2023 (actual)
Results: Posted 14 Jan 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: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)	Experimental	Drug: LY3493269, Drug: Sodium Caprate (C10)* Participants were administered oral doses of 4 milligram (mg) LY3493269 test capsule formulation 1, co-administered with 280 mg of sodium caprate (C10). * This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)	Experimental	Drug: LY3493269, Drug: Sodium Caprate (C10)* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10. * This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)	Experimental	Drug: LY3493269, Drug: Salcaprozate Sodium (SNAC)* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of salcaprozate sodium (SNAC). * This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
Part B: LY3493269	Experimental	Drug: LY3493269The formulation of the LY3493269 test capsule (1,2) or reference tablet were planned to be determined based on the initial review of safety and pharmacokinetic data from Part A.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female participants who are overtly healthy as determined by medical evaluation
Participants with body mass index (BMI) of 19.0 to 40.0 kilograms per meter squared (kg/m²)
Males who agree to use highly effective/effective methods of contraception and only women not of childbearing potential may participate in the trial

Key exclusion criteria (18 listed)

Have a history of atopy (severe or multiple allergic manifestations) or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis)
Have a significant history of or current cardiovascular (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, gastrointestinal (GI) including involving the liver, gallbladder or gallbladder surgery, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the investigational product (IP); or of interfering with the interpretation of data.
Have a mean supine heart rate (HR) less than 45 bpm or greater than 100 bpm from 2 assessments at screening.
Have a mean supine systolic blood pressure (BP) higher than 160 mmHg and a mean supine diastolic BP higher than 95 mmHg from 2 assessments at screening
Have undergone any form of bariatric surgery.

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
LY3493269Administered orally.	Drug	Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted), Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted), Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted), Part B: LY3493269
Sodium Caprate (C10)Administered orally.	Drug	Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted), Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
Salcaprozate Sodium (SNAC)Administered orally.	Drug	Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)

Primary outcome

Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269
Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose
PK: AUC (0-∞) of LY3493269
Part A: PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCτ) of LY3493269
Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose
PK: AUCτ of LY3493269
Part A: PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose
Cmax of LY3493269

Results and safety

Results posted to the registry on 14 Jan 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
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)	12	11
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)	15	12
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)	15	13

Primary outcome: Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269

Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter(ng*h/mL)

Measure	Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) n = 11	Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) n = 15	Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) n = 14
Value	1590 (100)	4880 (58)	12200 (112)

Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) vs Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted): Ratio of Geometric Least Squares Means: 0.130 (90% CI 0.0741 to 0.228), Mixed Models Analysis
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) vs Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted): Ratio of Geometric Least Squares Means: 0.399 (90% CI 0.237 to 0.669), Mixed Models Analysis

Population analysed: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.

Primary outcome: Part A: PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCτ) of LY3493269

Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter(ng*h/mL)

Measure	Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) n = 11	Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) n = 15	Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) n = 14
Value	150 (69)	402 (66)	1220 (108)

Population analysed: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.

Primary outcome: Part A: PK: Maximum Observed Drug Concentration (Cmax) of LY3493269

Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) n = 11	Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) n = 15	Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) n = 14
Value	7.49 (80)	25.8 (73)	70.4 (108)

Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) vs Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted): Ratio of Geometric Least Squares Means: 0.106 (90% CI 0.0620 to 0.182), Mixed Models Analysis
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) vs Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted): Ratio of Geometric Least Squares Means: 0.343 (90% CI 0.206 to 0.569), Mixed Models Analysis

Population analysed: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.

Adverse events

Time frame: Part A: Baseline to end of follow-up (up to 43 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)	1 of 11 (9.1%)	9 of 11 (81.8%)	0 of 11
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)	0 of 14 (0%)	11 of 14 (78.6%)	0 of 14

Limitations and caveats (from the sponsor): The study was terminated early, and Part B was not executed, as sufficient safety and pharmacokinetic data had already been obtained from Part A.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 LY3493269, Sodium Caprate (C10) and Salcaprozate Sodium (SNAC) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

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 3 inclusion and 18 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: stopped early, as of the sponsor's last update on 14 Jan 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 Singapore. 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. 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 14 Jan 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?

Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269 (time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose). The study lists 3 primary outcomes in all. 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 NCT05794243.

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 14 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.