HealthyPhase 1NCT04559568
A Study of LY3522348 in Healthy Participants
A Phase 1 study testing LY3522348 and Midazolam in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study in healthy participants is to learn more about the safety of LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3522348 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 17 Aug 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy as determined through medical evaluation including medical history and physical examination
- Have a body mass index of greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
- Have had a stable weight for one month prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Who cannot join
- 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 data analysis
- Have blood pressure of greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
- Have a history of fructosuria
- Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
About this study
Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single- and Multiple-Ascending Doses of LY3522348 in Healthy Participants
The main purpose of this study in healthy participants is to learn more about the safety of LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. This study has two parts: Part A will last up to about six weeks and Part B will last up to about eight weeks for each participant.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3522348Drug
Administered orally.
PlaceboDrug
Administered orally.
MidazolamDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Placebo | Placebo comparator | A single dose of Placebo administered orally on Day 1. Receives: Drug: Placebo |
| Part A: 5 milligrams (mg) LY3522348 | Experimental | A single dose of 5 mg LY3522348 administered orally on Day 1. Receives: Drug: LY3522348 |
| Part A: 15 mg LY3522348 | Experimental | A single dose of 15 mg LY3522348 administered orally on Day 1. Receives: Drug: LY3522348 |
| Part A: 50 mg LY3522348 | Experimental | A single dose of 50 mg LY3522348 administered orally on Day 1. Receives: Drug: LY3522348 |
| Part A: 150 mg LY3522348 | Experimental | A single dose of 150 mg LY3522348 administered orally on Day 1. Receives: Drug: LY3522348 |
| Part A: 380 mg LY3522348 | Experimental | A single dose of 380 mg LY3522348 administered orally on Day 1. Receives: Drug: LY3522348 |
| Part B: Placebo | Placebo comparator | Placebo administered orally once daily on Days 1-14. Receives: Drug: Placebo |
| Part B: Placebo + Midazolam | Experimental | Placebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15. Receives: Drug: Placebo; Drug: Midazolam |
| Part B: 50 mg LY3522348 | Experimental | 50 mg LY3522348 administered orally once daily on Days 1-14. Receives: Drug: LY3522348 |
| Part B: 120 mg LY3522348 | Experimental | 120 mg LY3522348 administered orally once daily on Days 1-14. Receives: Drug: LY3522348 |
| Part B: 290 mg LY3522348 + Midazolam | Experimental | 290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. Receives: Drug: LY3522348; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
Measured: Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
Secondary outcomes (4)
Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348
PK: AUC(0-tlast) of LY3522348
Measured: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)
Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348
PK: AUC(0-tlast) of LY3522348
Measured: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)
Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348
PK: Cmax of LY3522348
Measured: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)
Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348
PK: Cmax of LY3522348
Measured: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Oct 2020
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559568
- Sponsor's protocol ID
- 17808
- Other IDs
- J2U-MC-YBAA
- Status last verified
- Oct 2025
- First submitted
- 21 Sep 2020
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fukuda T, Thompson BR, Brouwers B, Qian HR, Wang W, Morse BL, LaBell ES, Durham TB, Konig M, Haupt A, Benson CT, MacKrell J. LY3522348, A New Ketohexokinase Inhibitor: A First-in-Human Study in Healthy Adults. Diabetes Ther. 2025 Jul;16(7):1399-1415. doi: 10.1007/s13300-025-01752-5. Epub 2025 May 13.
PubMed 40358849
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single- and Multiple-Ascending Doses of LY3522348 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04559568
- Acronym / sponsor ID
- 17808
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study in healthy participants is to learn more about the safety of LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. This study has two parts: Part A will last up to about six weeks and Part B will last up to about eight weeks for each participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A: Placebo | Placebo comparator | Drug: PlaceboA single dose of Placebo administered orally on Day 1. |
| Part A: 5 milligrams (mg) LY3522348 | Experimental | Drug: LY3522348A single dose of 5 mg LY3522348 administered orally on Day 1. |
| Part A: 15 mg LY3522348 | Experimental | Drug: LY3522348A single dose of 15 mg LY3522348 administered orally on Day 1. |
| Part A: 50 mg LY3522348 | Experimental | Drug: LY3522348A single dose of 50 mg LY3522348 administered orally on Day 1. |
| Part A: 150 mg LY3522348 | Experimental | Drug: LY3522348A single dose of 150 mg LY3522348 administered orally on Day 1. |
| Part A: 380 mg LY3522348 | Experimental | Drug: LY3522348A single dose of 380 mg LY3522348 administered orally on Day 1. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally once daily on Days 1-14. |
| Part B: Placebo + Midazolam | Experimental | Drug: Placebo, Drug: MidazolamPlacebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15. |
| Part B: 50 mg LY3522348 | Experimental | Drug: LY352234850 mg LY3522348 administered orally once daily on Days 1-14. |
| Part B: 120 mg LY3522348 | Experimental | Drug: LY3522348120 mg LY3522348 administered orally once daily on Days 1-14. |
| Part B: 290 mg LY3522348 + Midazolam | Experimental | Drug: LY3522348, Drug: Midazolam290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are overtly healthy as determined through medical evaluation including medical history and physical examination
- Have a body mass index of greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
- Have had a stable weight for one month prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Key exclusion criteria (4 listed)
- 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 data analysis
- Have blood pressure of greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
- Have a history of fructosuria
- Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study
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 |
|---|---|---|
| LY3522348Administered orally. | Drug | Part A: 15 mg LY3522348, Part A: 150 mg LY3522348, Part A: 380 mg LY3522348, Part A: 5 milligrams (mg) LY3522348, Part A: 50 mg LY3522348, Part B: 120 mg LY3522348, Part B: 290 mg LY3522348 + Midazolam, Part B: 50 mg LY3522348 |
| PlaceboAdministered orally. | Drug | Part A: Placebo, Part B: Placebo, Part B: Placebo + Midazolam |
| MidazolamAdministered orally. | Drug | Part B: 290 mg LY3522348 + Midazolam, Part B: Placebo + Midazolam |
Primary outcome
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
4 secondary outcomes
Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348
Time frame: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)
Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348
Time frame: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)
Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348
Time frame: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)
Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348
Time frame: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40358849Fukuda T, Thompson BR, Brouwers B, Qian HR, Wang W, Morse BL, LaBell ES, Durham TB, Konig M, Haupt A, Benson CT, MacKrell J. LY3522348, A New Ketohexokinase Inhibitor: A First-in-Human Study in Healthy Adults. Diabetes Ther. 2025 Jul;16(7):1399-1415. doi: 10.1007/s13300-025-01752-5. Epub 2025 May 13.
- 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 LY3522348 and Midazolam in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
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 4 inclusion and 4 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 4 Nov 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 United States. 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 4 Nov 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?
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Part A: Baseline up to Day 14; Part B: Baseline up to Day 28). 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 NCT04559568, which also lists 1 linked publication.
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 4 Nov 2025.