HealthyPhase 1NCT06964776
A Study of LY4268989 (MORF-057) in Healthy Participants
A Phase 1 study testing LY4268989 and Midazolam in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants 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?
- LY4268989 and Midazolam
- 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
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 17 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs.
- Cohort 5 includes Japanese participants. To qualify, the participants must be first-generation Japanese in the US, defined as the participant's biological parents, and all the participant's biological grandparents, being of exclusive Japanese descent, and being born in Japan.
- Cohort 5 includes Chinese participants. To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- Have a body mass index within the range of 18.0 to 32.0 kilogram/square meter (kg/m²), inclusive, at screening.
Who cannot join
- Have a current or recent acute, active infection. For at least 30 days before screening and up to Day 1, participants must have no symptoms or signs of confirmed or suspected infection, and must have completed any appropriate anti-infective treatment.
- Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the sponsor or investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data.
- Are immunocompromised to an extent that participation in the study would pose an unacceptable risk to the participant as determined by the investigator.
- Use or intend to use prescription or nonprescription medication, including dietary supplements, vitamins, herbal supplements, traditional Chinese medicine, or alternative medicines, within 14 days or 5 half-lives (whichever is longer), prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Further Investigate the Pharmacokinetics, Safety and Tolerability, Food Effect and Drug-Drug Interaction of LY4268989 (MORF-057) in Healthy Participants
The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4268989Drug
Administered orally
PlaceboDrug
Administered placebo
MidazolamDrug
Administered orally
MidazolamDrug
Administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| LY4268989 or Placebo Cohort 1 (Blinded) | Experimental | Participants will receive LY4268989 orally or placebo single dose followed by BID administration Receives: Drug: LY4268989; Drug: Placebo |
| LY4268989 Cohort 2 (Open-Label) | Experimental | Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state Receives: Drug: LY4268989 |
| LY4268989 Cohort 3 (Open-Label) | Experimental | Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV). Receives: Drug: LY4268989; Drug: Midazolam |
| LY4268989 or Placebo Cohort 4 (Blinded) | Experimental | Participants will receive single escalating doses of LY4268989 orally or placebo Receives: Drug: LY4268989; Drug: Placebo |
| LY4268989 Cohort 5 (Blinded) | Experimental | Participants will receive multiple doses of LY4268989 orally or placebo Receives: Drug: LY4268989; Drug: Placebo |
| LY4268989 Cohort 6 (Open-Label) | Experimental | Participants will receive LY4268989 single dose orally in a fasted and fed state Receives: Drug: LY4268989 |
| LY4268989 Cohort 7 (Open-Label) | Experimental | Participants will receive multiple doses of LY4268989 orally BID administration in a fed state Receives: Drug: LY4268989 |
| LY4268989 Cohort 8 (Open-Label) | Experimental | Participants will receive multiple doses of LY4268989 orally BID administration with midazolam IV in a fasted state. Receives: Drug: LY4268989; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5)
Measured: Day 1 to Day 17
PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5)
Measured: Day 1 to Day 17
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Cohort 1), (Cohort 3), and (Cohort 5)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
Measured: Baseline to Study Completion (Up to Day 17)
Number of Participants with TEAEs and SAEs (Cohort 4)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
Measured: Baseline to Study Completion (Up to Period 4, Day 4)
PK: Cmax of LY4268989 (Cohort 2)
Measured: Day 1 to Day 13
PK: AUC of LY4268989 (Cohort 2)
Measured: Day 1 to Day 13
PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
Measured: Day 1 to Day 17
PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 8)
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
Measured: Day 3 and Day 11
PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
Measured: Day 1 to Day 17
PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 8)
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
Measured: Day 3 to Day 11
PK: Cmax of LY4268989 (Cohort 6)
Measured: Day 1 to Day 7
PK: AUC of LY4268989 (Cohort 6)
Measured: Day 1 to Day 7
PK: Cmax of LY4268989 (Cohort 7)
Measured: Day 1 to Day 12
PK: AUC of LY4268989 (Cohort 7)
Measured: Day 1 to Day 12
Secondary outcomes (6)
PK: Cmax of LY4268989 (Cohort 4)
Measured: Day 1 to Day 4
PK: AUC of LY4268989 (Cohort 4)
Measured: Day 1 to Day 4
PK: Cmax of LY4268989 (Cohort 3)
Measured: Time Frame: Day 6 to Day 15
PK: AUC of LY4268989 (Cohort 3)
Measured: Time Frame: Day 6 to Day 15
PK: Cmax of LY4268989 (Cohort 8)
Measured: Time Frame: Day 3 and Day 10
PK: AUC of LY4268989 (Cohort 8)
Measured: Time Frame: Day 3 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 May 2025
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
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
- 144 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964776
- Sponsor's protocol ID
- 27387
- Other IDs
- J6E-MC-KWAC, MORF-057
- Status last verified
- Mar 2026
- First submitted
- 1 May 2025
- Last updated
- 27 Mar 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Further Investigate the Pharmacokinetics, Safety and Tolerability, Food Effect and Drug-Drug Interaction of LY4268989 (MORF-057) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06964776
- Acronym / sponsor ID
- 27387
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 9 May 2025 (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 purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| LY4268989 or Placebo Cohort 1 (Blinded) | Experimental | Drug: LY4268989, Drug: PlaceboParticipants will receive LY4268989 orally or placebo single dose followed by BID administration |
| LY4268989 Cohort 2 (Open-Label) | Experimental | Drug: LY4268989Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state |
| LY4268989 Cohort 3 (Open-Label) | Experimental | Drug: LY4268989, Drug: MidazolamParticipants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV). |
| LY4268989 or Placebo Cohort 4 (Blinded) | Experimental | Drug: LY4268989, Drug: PlaceboParticipants will receive single escalating doses of LY4268989 orally or placebo |
| LY4268989 Cohort 5 (Blinded) | Experimental | Drug: LY4268989, Drug: PlaceboParticipants will receive multiple doses of LY4268989 orally or placebo |
| LY4268989 Cohort 6 (Open-Label) | Experimental | Drug: LY4268989Participants will receive LY4268989 single dose orally in a fasted and fed state |
| LY4268989 Cohort 7 (Open-Label) | Experimental | Drug: LY4268989Participants will receive multiple doses of LY4268989 orally BID administration in a fed state |
| LY4268989 Cohort 8 (Open-Label) | Experimental | Drug: LY4268989, Drug: MidazolamParticipants will receive multiple doses of LY4268989 orally BID administration with midazolam IV in a fasted state. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs.
- Cohort 5 includes Japanese participants. To qualify, the participants must be first-generation Japanese in the US, defined as the participant's biological parents, and all the participant's biological grandparents, being of exclusive Japanese descent, and being born in Japan.
- Cohort 5 includes Chinese participants. To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- Have a body mass index within the range of 18.0 to 32.0 kilogram/square meter (kg/m²), inclusive, at screening.
Key exclusion criteria (4 listed)
- Have a current or recent acute, active infection. For at least 30 days before screening and up to Day 1, participants must have no symptoms or signs of confirmed or suspected infection, and must have completed any appropriate anti-infective treatment.
- Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the sponsor or investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data.
- Are immunocompromised to an extent that participation in the study would pose an unacceptable risk to the participant as determined by the investigator.
- Use or intend to use prescription or nonprescription medication, including dietary supplements, vitamins, herbal supplements, traditional Chinese medicine, or alternative medicines, within 14 days or 5 half-lives (whichever is longer), prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with 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 |
|---|---|---|
| LY4268989Administered orally | Drug | LY4268989 Cohort 2 (Open-Label), LY4268989 Cohort 3 (Open-Label), LY4268989 Cohort 5 (Blinded), LY4268989 Cohort 6 (Open-Label), LY4268989 Cohort 7 (Open-Label), LY4268989 Cohort 8 (Open-Label), LY4268989 or Placebo Cohort 1 (Blinded), LY4268989 or Placebo Cohort 4 (Blinded) |
| PlaceboAdministered placebo | Drug | LY4268989 Cohort 5 (Blinded), LY4268989 or Placebo Cohort 1 (Blinded), LY4268989 or Placebo Cohort 4 (Blinded) |
| MidazolamAdministered orally | Drug | LY4268989 Cohort 3 (Open-Label) |
| MidazolamAdministered intravenously (IV) | Drug | LY4268989 Cohort 3 (Open-Label), LY4268989 Cohort 8 (Open-Label) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5)
Time frame: Day 1 to Day 17
PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5)
Time frame: Day 1 to Day 17
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Cohort 1), (Cohort 3), and (Cohort 5)
Time frame: Baseline to Study Completion (Up to Day 17)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
Number of Participants with TEAEs and SAEs (Cohort 4)
Time frame: Baseline to Study Completion (Up to Period 4, Day 4)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
PK: Cmax of LY4268989 (Cohort 2)
Time frame: Day 1 to Day 13
PK: AUC of LY4268989 (Cohort 2)
Time frame: Day 1 to Day 13
PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
Time frame: Day 1 to Day 17
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 8)
Time frame: Day 3 and Day 11
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
Time frame: Day 1 to Day 17
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 8)
Time frame: Day 3 to Day 11
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
PK: Cmax of LY4268989 (Cohort 6)
Time frame: Day 1 to Day 7
PK: AUC of LY4268989 (Cohort 6)
Time frame: Day 1 to Day 7
PK: Cmax of LY4268989 (Cohort 7)
Time frame: Day 1 to Day 12
PK: AUC of LY4268989 (Cohort 7)
Time frame: Day 1 to Day 12
6 secondary outcomes
PK: Cmax of LY4268989 (Cohort 4)
Time frame: Day 1 to Day 4
PK: AUC of LY4268989 (Cohort 4)
Time frame: Day 1 to Day 4
PK: Cmax of LY4268989 (Cohort 3)
Time frame: Time Frame: Day 6 to Day 15
PK: AUC of LY4268989 (Cohort 3)
Time frame: Time Frame: Day 6 to Day 15
PK: Cmax of LY4268989 (Cohort 8)
Time frame: Time Frame: Day 3 and Day 10
PK: AUC of LY4268989 (Cohort 8)
Time frame: Time Frame: Day 3 and Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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 8 AM - 8 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 LY4268989 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 27 Mar 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5) (time frame: Day 1 to Day 17). The study lists 14 primary outcomes in all. 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 27 Mar 2026.