LY4268989 for Healthy Subjects

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Prescription medications

Disqualifiers: Infections, Uncontrolled disorders, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 17 days

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on how the body absorbs and processes a new drug, LY4268989, to ensure safety and tolerance. Researchers are testing the drug across several groups, possibly including a placebo for comparison. The study targets healthy individuals, including those of Japanese or Chinese descent, without significant health issues and not on medications. Participants should have a healthy body mass index and no recent infections. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications, including dietary supplements and herbal remedies, at least 14 days before the study starts, unless the study team decides they won't interfere with the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies tested LY4268989 (also known as MORF-057) on healthy individuals to assess its safety and tolerability. These studies examined how the body processes the drug and its effects. The results showed that LY4268989 is generally well-tolerated, with most participants experiencing no serious side effects. No major safety concerns have been reported so far. This Phase 1 trial primarily focuses on ensuring the treatment's safety for humans. Such early trials are crucial for identifying potential issues before further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY4268989 because it offers a new approach to treatment with its unique oral administration in both tablet and capsule forms. Unlike current treatments that may have limited flexibility in dosing, LY4268989 involves both single and multiple dose regimens, potentially allowing for more personalized treatment plans. Additionally, the combination of LY4268989 with midazolam could offer insights into drug interactions and optimize effectiveness, setting it apart from existing options. Overall, this treatment's novel features and potential for diverse applications make it a promising candidate for advancing therapeutic strategies.

What evidence suggests that this trial's treatments could be effective?

Initial findings suggest that LY4268989 (MORF-057) may work by affecting a specific biological process. This process resembles one targeted by certain drugs used in other treatments, which have shown positive effects in patients. Early research indicates that LY4268989 produced effects in healthy participants similar to those seen in treatments targeting this process. Although more data is needed, these initial results are promising, suggesting the drug might be effective for future conditions involving this process. ^{1 3 5 6 7}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy individuals, including those of Japanese and Chinese descent. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

Cohort 5 includes Japanese participants who 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 born in Japan

Have a body mass index within the range of 18.0 to 32.0 kilogram/square meter (kilogram/m²), inclusive, at screening

I am healthy based on recent medical exams and tests.

Exclusion Criteria

Are immunocompromised to an extent that participation in the study would pose an unacceptable risk

I have used or plan to use medication or supplements within 14 days before starting the trial.

I haven't had symptoms or signs of an infection for at least 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4268989 or placebo in various cohorts, including single and multiple doses, with some cohorts involving midazolam administration

Up to 17 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of TEAEs and SAEs

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4268989

Trial Overview The study is testing LY4268989 (MORF-057), comparing it to a placebo and Midazolam. It aims to understand how LY4268989 is absorbed, processed by the body, its effects on the body, as well as its safety and tolerability in healthy people.

How Is the Trial Designed?

Group I: LY4268989 or Placebo Cohort 4 (Blinded) Experimental Treatment 2 Interventions

Participants will receive single escalating doses of LY4268989 orally or placebo

Group II: LY4268989 or Placebo Cohort 1 (Blinded) Experimental Treatment 2 Interventions

Participants will receive LY4268989 orally or placebo single dose followed by BID administration

Group III: LY4268989 Cohort 7 (Open-Label) Experimental Treatment 1 Intervention

Participants will receive multiple doses of LY4268989 orally BID administration in a fed state

Group IV: LY4268989 Cohort 6 (Open-Label) Experimental Treatment 1 Intervention

Participants will receive LY4268989 single dose orally in a fasted and fed state

Group V: LY4268989 Cohort 5 (Blinded) Experimental Treatment 2 Interventions

Participants will receive multiple doses of LY4268989 orally or placebo

Group VI: LY4268989 Cohort 3 (Open-Label) Experimental Treatment 2 Interventions

Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV).

Group VII: LY4268989 Cohort 2 (Open-Label) Experimental Treatment 1 Intervention

Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06964776

A Study of LY4268989 (MORF-057) in Healthy Participants The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07186101

Study Details | NCT07186101 | LY4268989 (MORF-057) ... The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult ...

3. prnewswire.com prnewswire.com/news-releases/lillys-omvoh-mirikizumab-mrkz-demonstrated-early-and-sustained-improvement-in-bowel-urgency-outcomes-for-patients-with-ulcerative-colitis-302594395.html

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and ... Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis.

4. sigma.larvol.com sigma.larvol.com/product.php?e1=824053&tab=newstrac

LY4268989 News Effects observed were consistent with those reported for patients receiving biologic inhibitors of the same pathway as well as in healthy volunteers receiving ...

5. morningstar.com morningstar.com/news/pr-newswire/20251007de91004/lillys-omvoh-mirikizumab-mrkz-is-the-first-and-only-il-23p19-antagonist-to-show-four-years-of-sustained-corticosteroid-free-comprehensive-patient-outcomes-in-ulcerative-colitis

Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL ... Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 antagonist to show four years of sustained, corticosteroid-free comprehensive ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly4268989-morf-057-in-healthy-participants

A Study 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.

7. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/34670547/eli-lillys-new-phase-1-study-a-potential-game-changer/

Eli Lilly's New Phase 1 Study: A Potential Game Changer? ' The study aims to assess how the body absorbs and processes LY4268989, its safety, and tolerability in healthy individuals, including Japanese ...