LY4268989 for Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how the body processes a drug called LY4268989, a new potential treatment, when taken as different types of tablets with or without food. Researchers seek to understand if the tablets function similarly in healthy individuals under these varying conditions. The trial includes blood tests and several stays at a research facility over approximately 9 weeks. It seeks healthy participants without recent infections or significant untreated health issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LY4268989 is generally safe in clinical studies. Participants in past trials have not reported any serious side effects. For instance, one study found no major safety issues when LY4268989 was used with another drug, mirikizumab. In another trial, only three minor unwanted effects were reported, none of which were linked to LY4268989. These findings suggest that the treatment is safe for people in the trials.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about LY4268989 because it offers a novel approach to drug delivery and absorption based on dietary conditions. Unlike standard treatments that have a fixed method of intake, LY4268989's effectiveness is being tested in both fed and fasted states, potentially leading to a more flexible dosing regimen. By understanding how a high-fat meal or fasting affects the drug's absorption, this treatment could offer more personalized options for patients, potentially improving efficacy and convenience. Additionally, the exploration of different single-dose formulations (T1, T2, and T3) could reveal insights into optimizing the drug's performance.
What evidence suggests that this trial's treatments could be effective?
Research has shown that LY4268989, also known as MORF-057, may help treat certain conditions when combined with mirikizumab. Studies have found this combination effective and safe, with no major safety issues reported. Some patients taking higher doses of LY4268989 experienced better results, including symptom relief. Although the results were not always statistically significant, they suggest possible benefits. Overall, LY4268989 is well-tolerated, making it a candidate for further research into its effectiveness.
In this trial, participants will receive different single doses of LY4268989 under various conditions, such as with a high-fat meal or in a fasted state, to evaluate its safety and tolerability in healthy individuals.12346Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants should be willing to stay at the research center multiple times over about 9 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single doses of LY4268989 under different meal conditions to assess pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4268989
Trial Overview
The study is testing two different tablet forms of LY4268989 (MORF 057) in healthy people, looking at how the body absorbs and processes each form when taken with different meals. It involves blood tests and several short stays at a clinic.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Participants will receive LY4268989 single dose T1 orally in a fasted state
Participants will receive LY4268989 single dose T3 orally in a fasted state
Participants will receive LY4268989 single dose T3 orally with high-fat meal
Participants will receive LY4268989 single dose T2 orally in a fasted state
Participants will receive LY4268989 single dose T2 orally with high-fat meal
Participants will receive LY4268989 single dose T1 orally with high-fat meal
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
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 ...
LY4268989 for Healthy Subjects · Info for Participants
The results showed that LY4268989 is generally well-tolerated, with most participants experiencing no serious side effects. No major safety concerns have been ...
LY4268989 (zotemtegrast) Co-Administered With ... - Lilly Trials
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 ...
Zotemtegrast - Drug Targets, Indications, Patents
ability of LY4268989 (MORF-057) in Healthy Participants … 22.9% of participants (8/35) achieved RHI remission (RHI score ≤3).
zotemtegrast (LY4268989) / Schrodinger, Eli Lilly
Study of LY4268989 (MORF. Healthy Participants … was numerically higher but did not achieve statistical significance vs. placebo, which showed higher-than- ...
Clinical Trials
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 ...
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