Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J2U-MC-YBAA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Placebo | Placebo Comparator | A single dose of Placebo administered orally on Day 1. |
|
| Part A: 5 milligrams (mg) LY3522348 | Experimental | A single dose of 5 mg LY3522348 administered orally on Day 1. |
|
| Part A: 15 mg LY3522348 | Experimental | A single dose of 15 mg LY3522348 administered orally on Day 1. |
|
| Part A: 50 mg LY3522348 | Experimental | A single dose of 50 mg LY3522348 administered orally on Day 1. |
|
| Part A: 150 mg LY3522348 | Experimental | A single dose of 150 mg LY3522348 administered orally on Day 1. |
|
| Part A: 380 mg LY3522348 | Experimental | A single dose of 380 mg LY3522348 administered orally on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3522348 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Part A: Baseline up to Day 14; Part B: Baseline up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40358849 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Placebo | A single dose of Placebo administered orally on Day 1. |
| FG001 | Part A: 5 mg LY3522348 | A single dose of 5 mg LY3522348 administered orally on Day 1. |
| FG002 | Part A: 15 mg LY3522348 | A single dose of 15 mg LY3522348 administered orally on Day 1. |
| FG003 | Part A: 50 mg LY3522348 | A single dose of 50 mg LY3522348 administered orally on Day 1. |
| FG004 | Part A: 150 mg LY3522348 | A single dose of 150 mg LY3522348 administered orally on Day 1. |
| FG005 | Part A: 380 mg LY3522348 | A single dose of 380 mg LY3522348 administered orally on Day 1. |
| FG006 | Part B: Placebo | Placebo administered orally once daily on Days 1-14. |
| FG007 | Part B: Placebo + Midazolam | Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. |
| FG008 | Part B: 50 mg LY3522348 | 50 mg LY3522348 administered orally once daily on Days 1-14. |
| FG009 | Part B: 120 mg LY3522348 | 120 mg LY3522348 administered orally once daily on Days 1-14. |
| FG010 | Part B: 290 mg LY3522348 + Midazolam | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Placebo | A single dose of Placebo administered orally on Day 1. |
| BG001 | Part A: 5 mg LY3522348 | A single dose of 5 mg LY3522348 administered orally on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled participants, irrespective of the completion of all protocol requirements. | Posted | Count of Participants | Participants | No | Part A: Baseline up to Day 14; Part B: Baseline up to Day 28 |
|
Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Placebo | A single dose of Placebo administered orally on Day 1. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2021 | Sep 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2021 | Sep 7, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part B: Placebo | Placebo Comparator | Placebo administered orally once daily on Days 1-14. |
|
| 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. |
|
| Part B: 50 mg LY3522348 | Experimental | 50 mg LY3522348 administered orally once daily on Days 1-14. |
|
| Part B: 120 mg LY3522348 | Experimental | 120 mg LY3522348 administered orally once daily on Days 1-14. |
|
| 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. |
|
| Placebo | Drug | Administered orally. |
|
| Midazolam | Drug | Administered orally. |
|
PK: AUC(0-tlast) of LY3522348 |
| 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 | 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 | 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) |
| Withdrawal by Subject |
|
| BG002 | Part A: 15 mg LY3522348 | A single dose of 15 mg LY3522348 administered orally on Day 1. |
| BG003 | Part A: 50 mg LY3522348 | A single dose of 50 mg LY3522348 administered orally on Day 1. |
| BG004 | Part A: 150 mg LY3522348 | A single dose of 150 mg LY3522348 administered orally on Day 1. |
| BG005 | Part A: 380 mg LY3522348 | A single dose of 380 mg LY3522348 administered orally on Day 1. |
| BG006 | Part B: Placebo | Placebo administered orally once daily on Days 1-14. |
| BG007 | Part B: Placebo + Midazolam | Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. |
| BG008 | Part B: 50 mg LY3522348 | 50 mg LY3522348 administered orally once daily on Days 1-14. |
| BG009 | Part B: 120 mg LY3522348 | 120 mg LY3522348 administered orally once daily on Days 1-14. |
| BG010 | Part B: 290 mg LY3522348 + Midazolam | 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. |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Part A: Placebo |
A single dose of Placebo administered orally on Day 1. |
| OG001 | Part A: 5 mg LY3522348 | A single dose of 5 mg LY3522348 administered orally on Day 1. |
| OG002 | Part A: 15 mg LY3522348 | A single dose of 15 mg LY3522348 administered orally on Day 1. |
| OG003 | Part A: 50 mg LY3522348 | A single dose of 50 mg LY3522348 administered orally on Day 1. |
| OG004 | Part A: 150 mg LY3522348 | A single dose of 150 mg LY3522348 administered orally on Day 1. |
| OG005 | Part A: 380 mg LY3522348 | A single dose of 380 mg LY3522348 administered orally on Day 1. |
| OG006 | Part B: Placebo | Placebo administered orally once daily on Days 1-14. |
| OG007 | Part B: Placebo + Midazolam | Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. |
| OG008 | Part B: 50 mg LY3522348 | 50 mg LY3522348 administered orally once daily on Days 1-14. |
| OG009 | Part B: 120 mg LY3522348 | 120 mg LY3522348 administered orally once daily on Days 1-14. |
| OG010 | Part B: 290 mg LY3522348 + Midazolam | 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. |
|
|
| Secondary | 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 | All enrolled participants in Part A who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/milliliter (μg*h/mL) | Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose) |
|
|
|
| Secondary | 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 | All enrolled participants in Part B who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | 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) |
|
|
|
| Secondary | Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348 | PK: Cmax of LY3522348 | All enrolled participants in Part A who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/mililiter (μg/mL) | Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose) |
|
|
|
| Secondary | Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348 | PK: Cmax of LY3522348 | All enrolled participants in Part B who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 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) |
|
|
|
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Part A: 5 mg LY3522348 | A single dose of 5 mg LY3522348 administered orally on Day 1. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Part A: 15 mg LY3522348 | A single dose of 15 mg LY3522348 administered orally on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Part A: 50 mg LY3522348 | A single dose of 50 mg LY3522348 administered orally on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part A: 150 mg LY3522348 | A single dose of 150 mg LY3522348 administered orally on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Part A: 380 mg LY3522348 | A single dose of 380 mg LY3522348 administered orally on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | Part B: Placebo | Placebo administered orally once daily on Days 1-14. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG007 | Part B: Placebo + Midazolam | Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG008 | Part B: 50 mg LY3522348 | 50 mg LY3522348 administered orally once daily on Days 1-14. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG009 | Part B: 120 mg LY3522348 | 120 mg LY3522348 administered orally once daily on Days 1-14. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG010 | Part B: 290 mg LY3522348 + Midazolam | 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. | 0 | 7 | 0 | 7 | 1 | 7 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Medical device site dermatitis | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| D006571 | Heterocyclic Compounds |
| Day 14 |
|
|
| Day 14 |
|
|