HealthyPhase 1NCT07339722
A Study of LY4515100 in Healthy Participants
A Phase 1 study testing LY4515100 via SAD, LY4515100 via MAD and LY4515100 in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. LY4515100 will be given by itself or with other medicines. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. 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?
- LY4515100 via SAD, LY4515100 via MAD and LY4515100
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring.
- Have a body mass index (BMI) within the range of 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive).
- Individuals not of childbearing potential (INOCBP) may participate in this trial.
- Participants in the Combined Oral Contraceptive Arm of Part C only:
- must be 18 to 45 years of age (inclusive).
- have a BMI within the range of 18.5 to 30 kg/m².
- may be healthy pre-menopausal assigned female at birth (AFAB) individuals of child bearing potential (IOCBP).
Who cannot join
- Have donated 500 milliliters (mL) of blood within 30 days prior to dosing.
- Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous investigational product (IP) has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed.
- Participants with hemoglobin outside of the local laboratory normal reference range for age and sex, which is judged to be clinically significant by the investigator.
- Participants with an estimated glomerular filtration rate less than (<) 90 milliliter per minute per 1.73 square meters (mL/min/1.73 m²).
- Have a 12-lead Electrocardiogram (ECG) abnormality that, in the opinion of the investigator,
- increases the risks associated with participating in the study
Show all 29Show fewer
- may confound ECG data analysis
- Have used or intend to use over-the-counter or prescription medication including dietary or herbal medications within 7 days, or 14 days if the medication is a potential enzyme inducer, or 5 half-lives (whichever is longer), prior to dosing.
- Smoke more than 10 cigarettes per day or the equivalent, including electronic cigarettes, and are unable to abide by investigative site smoking restrictions.
- Have an average weekly alcohol intake that exceeds 14 units per week (males 65 years of age or younger) and 7 units per week (females and males greater than 65 years of age, if applicable)
- Show evidence of
- Human immunodeficiency virus (HIV) infection and/or positive human HIV antigen and/or antibodies
- hepatitis C and/or positive hepatitis C antibody
- hepatitis B and/or positive hepatitis B surface antigen.
- Have liver disease.
- Any clinical condition or procedure (for example, gastrointestinal obstruction, gastric bypass, or cholecystectomy) that may affect the absorption, distribution, or excretion of the study drug and confound pharmacokinetics (PK) assessment.
- Part C Only:
- Have history of neuropathy of any cause.
- Have impaired hearing or a history of hearing problems.
- Have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information, such as prior history of hypersensitivity to itraconazole or other azoles.
- Participants with any known history of thyroid disease
- Participants in the Combined Oral Contraceptive Arm of Part C only:
- Are current smokers or have used nicotine, including tobacco or nicotine replacement products within 14 days prior to the first dose of combined oral contraceptive (COC), or plan to use nicotine, including tobacco or nicotine replacement products during the study.
- Are at high risk for arterial or venous thrombotic diseases, autoimmune disease with lupus anticoagulants or anti-phospholipid syndrome, major surgery within the past 3 months, anticipated prolonged immobility.
- Have abnormalities indicative of increased risk of VTE on the thrombophilia panel at screening.
- Have undiagnosed abnormal uterine bleeding.
- Have any history of breast, uterine or ovarian cancer.
- Use of Vitamin C (greater than or equal to (≥) 500 mg/day) or acetaminophen within 14 days before dosing.
- Have contraindications for the use of levonorgestrel/ethinyl estradiol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States2 sites, 2 recruiting
- Recruiting
Fortrea Clinical Research Unit
Dallas, Texas, 75247
866-429-3700
Gene Voskuhl
- Not yet recruiting
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
866-429-3700
Kimberly Cruz
About this study
Official title: A Phase 1, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, and Pharmacokinetics of LY4515100 in Healthy Participants and an Open-Label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of LY4515100 and of LY4515100 on the Pharmacokinetics of CYP and Transporter Substrates in Healthy Participants
The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. LY4515100 will be given by itself or with other medicines. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will have 3 parts and will last about 50 days. For each participant in Part A, the study will include a stay in the Clinical Research Unit (CRU) lasting about 6 days. For each participant in Part B, the study will include a stay in the CRU lasting about 15 days. For each participant in Part C, the study will include up to 2 stays in the CRU each lasting between 7-28 days.
- Conditions
- Healthy
- Being tested
- LY4515100 via SAD, LY4515100 via MAD, LY4515100, Itraconazole, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4515100 via SADDrug
given orally
LY4515100 via MADDrug
given orally
LY4515100Drug
given orally
ItraconazoleDrug
given orally
CaffeineDrug
given orally
DigoxinDrug
given orally
IohexolDrug
given IV
MetforminDrug
given orally
RosuvastatinDrug
given orally
PlaceboDrug
given orally
MidazolamDrug
given orally
MidazolamDrug
given IV
LevonorgestrelDrug
given orally
Ethinyl EstradiolDrug
given orally
| Study group | Role | What they receive |
|---|---|---|
| LY4515100 of Part A (SAD) | Experimental | Single-ascending doses of LY4515100 will be given orally Receives: Drug: LY4515100 via SAD |
| LY4515100 of Part B (MAD) | Experimental | Multiple-ascending doses of LY4515100 will be given orally Receives: Drug: LY4515100 via MAD |
| LY4515100 and Itraconazole of Part C | Experimental | LY4515100 and Itraconazole will be given orally Receives: Drug: LY4515100; Drug: Itraconazole |
| LY4515100 and Metformin of Part C | Experimental | LY4515100 and Metformin will be given orally Receives: Drug: LY4515100; Drug: Metformin |
| LY4515100 and Transporter Substrates or Renal Marker of Part C | Experimental | LY4515100 and Transporter Substrates or Renal Marker will be given either orally or intravenously (IV) Receives: Drug: LY4515100; Drug: Caffeine; Drug: Digoxin; Drug: Iohexol; Drug: Rosuvastatin |
| LY4515100 and Midazolam of Part C | Experimental | LY4515100 will be given orally. Midazolam will be given orally and IV. Receives: Drug: LY4515100; Drug: Midazolam |
| LY4515100 and Combined Oral Contraceptive of Part C | Experimental | LY4515100, Levonorgestrel, and Ethinyl Estradiol will be given orally Receives: Drug: LY4515100; Drug: Levonorgestrel; Drug: Ethinyl Estradiol |
| Placebo Part A | Placebo comparator | Placebo will be given orally Receives: Drug: Placebo |
| Placebo Part B | Placebo comparator | Placebo will be given orally Receives: Drug: Placebo |
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) of LY4515100 in Parts A and B
SAEs of LY4515100
Measured: Day 1 up to Day 30
Secondary outcomes (7)
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY4515100
PK: AUC of LY4515100
Measured: Day 1 through Day 11
PK: Maximum Observed Drug Concentration (Cmax) of LY4515100
PK: Cmax of LY4515100
Measured: Day 1 through Day 11
PK: Time of maximum observed drug concentration (tmax) of LY4515100
PK: tmax of LY4515100
Measured: Day 1 through Day 11
PK: Geometric Means of Area Under the Concentration-Time Curve From 0 to Infinity [AUC(0-∞)] of LY4515100 in Combination with Itraconazole versus LY4515100 Alone
Measured: Day 1 through Day 50
PK: Geometric Means of Cmax of LY4515100 in Combination with Itraconazole versus LY4515100 Alone
Measured: Day 1 through Day 50
PK: Geometric Means of AUC(0-∞) of Substrate in Combination with LY4515100 versus Substrate Alone
Measured: Day 1 through Day 36
PK: Geometric Means of Cmax of Substrate in Combination with LY4515100 versus Substrate Alone
Measured: Day 1 through Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 209 participants (estimated)
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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339722
- Sponsor's protocol ID
- 27789
- Other IDs
- J6V-MC-OIAB
- Status last verified
- Nov 2026
- First submitted
- 6 Jan 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, and Pharmacokinetics of LY4515100 in Healthy Participants and an Open-Label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of LY4515100 and of LY4515100 on the Pharmacokinetics of CYP and Transporter Substrates in Healthy Participants
- ClinicalTrials.gov ID
- NCT07339722
- Acronym / sponsor ID
- 27789
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
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 is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. LY4515100 will be given by itself or with other medicines. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will have 3 parts and will last about 50 days. For each participant in Part A, the study will include a stay in the Clinical Research Unit (CRU) lasting about 6 days. For each participant in Part B, the study will include a stay in the CRU lasting about 15 days. For each participant in Part C, the study will include up to 2 stays in the CRU each lasting between 7-28 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| LY4515100 of Part A (SAD) | Experimental | Drug: LY4515100 via SADSingle-ascending doses of LY4515100 will be given orally |
| LY4515100 of Part B (MAD) | Experimental | Drug: LY4515100 via MADMultiple-ascending doses of LY4515100 will be given orally |
| LY4515100 and Itraconazole of Part C | Experimental | Drug: LY4515100, Drug: ItraconazoleLY4515100 and Itraconazole will be given orally |
| LY4515100 and Metformin of Part C | Experimental | Drug: LY4515100, Drug: MetforminLY4515100 and Metformin will be given orally |
| LY4515100 and Transporter Substrates or Renal Marker of Part C | Experimental | Drug: LY4515100, Drug: Caffeine, Drug: Digoxin, Drug: Iohexol, Drug: RosuvastatinLY4515100 and Transporter Substrates or Renal Marker will be given either orally or intravenously (IV) |
| LY4515100 and Midazolam of Part C | Experimental | Drug: LY4515100, Drug: MidazolamLY4515100 will be given orally. Midazolam will be given orally and IV. |
| LY4515100 and Combined Oral Contraceptive of Part C | Experimental | Drug: LY4515100, Drug: Levonorgestrel, Drug: Ethinyl EstradiolLY4515100, Levonorgestrel, and Ethinyl Estradiol will be given orally |
| Placebo Part A | Placebo comparator | Drug: PlaceboPlacebo will be given orally |
| Placebo Part B | Placebo comparator | Drug: PlaceboPlacebo will be given orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring.
- Have a body mass index (BMI) within the range of 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive).
- Individuals not of childbearing potential (INOCBP) may participate in this trial.
- Participants in the Combined Oral Contraceptive Arm of Part C only:
Key exclusion criteria (29 listed)
- Have donated 500 milliliters (mL) of blood within 30 days prior to dosing.
- Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous investigational product (IP) has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed.
- Participants with hemoglobin outside of the local laboratory normal reference range for age and sex, which is judged to be clinically significant by the investigator.
- Participants with an estimated glomerular filtration rate less than (<) 90 milliliter per minute per 1.73 square meters (mL/min/1.73 m²).
- Have a 12-lead Electrocardiogram (ECG) abnormality that, in the opinion of the investigator,
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 |
|---|---|---|
| LY4515100 via SADgiven orally | Drug | LY4515100 of Part A (SAD) |
| LY4515100 via MADgiven orally | Drug | LY4515100 of Part B (MAD) |
| LY4515100given orally | Drug | LY4515100 and Combined Oral Contraceptive of Part C, LY4515100 and Itraconazole of Part C, LY4515100 and Metformin of Part C, LY4515100 and Midazolam of Part C, LY4515100 and Transporter Substrates or Renal Marker of Part C |
| Itraconazolegiven orally | Drug | LY4515100 and Itraconazole of Part C |
| Caffeinegiven orally | Drug | LY4515100 and Transporter Substrates or Renal Marker of Part C |
| Digoxingiven orally | Drug | LY4515100 and Transporter Substrates or Renal Marker of Part C |
| Iohexolgiven IV | Drug | LY4515100 and Transporter Substrates or Renal Marker of Part C |
| Metformingiven orally | Drug | LY4515100 and Metformin of Part C |
| Rosuvastatingiven orally | Drug | LY4515100 and Transporter Substrates or Renal Marker of Part C |
| Placebogiven orally | Drug | Placebo Part A, Placebo Part B |
| Midazolamgiven orally | Drug | LY4515100 and Midazolam of Part C |
| Midazolamgiven IV | Drug | LY4515100 and Midazolam of Part C |
| Levonorgestrelgiven orally | Drug | LY4515100 and Combined Oral Contraceptive of Part C |
| Ethinyl Estradiolgiven orally | Drug | LY4515100 and Combined Oral Contraceptive of Part C |
Primary outcome
Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 in Parts A and B
Time frame: Day 1 up to Day 30
SAEs of LY4515100
7 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY4515100
Time frame: Day 1 through Day 11
PK: Maximum Observed Drug Concentration (Cmax) of LY4515100
Time frame: Day 1 through Day 11
PK: Time of maximum observed drug concentration (tmax) of LY4515100
Time frame: Day 1 through Day 11
PK: Geometric Means of Area Under the Concentration-Time Curve From 0 to Infinity [AUC(0-∞)] of LY4515100 in Combination with Itraconazole versus LY4515100 Alone
Time frame: Day 1 through Day 50
PK: Geometric Means of Cmax of LY4515100 in Combination with Itraconazole versus LY4515100 Alone
Time frame: Day 1 through Day 50
PK: Geometric Means of AUC(0-∞) of Substrate in Combination with LY4515100 versus Substrate Alone
Time frame: Day 1 through Day 36
PK: Geometric Means of Cmax of Substrate in Combination with LY4515100 versus Substrate Alone
Time frame: Day 1 through Day 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4515100 via SAD, LY4515100 via MAD and LY4515100 in people with Healthy, run by Eli Lilly and Company at 2 sites 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 7 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. 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) of LY4515100 in Parts A and B (time frame: Day 1 up to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.