LY4100511 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By This is a single site in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Disqualifiers: ECG abnormalities, Recent infection, Tuberculosis, Immunocompromised, Allergies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new drug, LY4100511 (also known as DC-853), in healthy individuals. Researchers are examining how the drug works alone and in combination with other common medications. Participants will take LY4100511 along with drugs like midazolam, repaglinide, digoxin, or rosuvastatin in different groups. This study suits healthy individuals with a body mass index (BMI) between 18 and 32 who are comfortable using contraception. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

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

Research has shown that LY4100511 was tested for safety in both healthy individuals and those with conditions like plaque psoriasis. In these studies, LY4100511 was generally well-tolerated. Although specific side effects weren't listed, ongoing research suggests that serious problems haven't been common. This trial is in an early stage, primarily aiming to gather more information about safety. Therefore, safety data is still being collected and reviewed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY4100511 because it represents a new frontier in drug interaction studies. Unlike existing treatments that typically focus on a single drug's efficacy and safety, LY4100511 is being tested in combination with other medications like midazolam, repaglinide, digoxin, and rosuvastatin to understand its interactions. This approach could lead to more tailored and effective treatment plans by revealing how LY4100511 interacts with different drugs, potentially improving both safety and efficacy in real-world scenarios. The study's focus on drug interactions is crucial for advancing personalized medicine and ensuring safe concurrent use of multiple medications.

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

Research has shown that LY4100511 is under study as a potential treatment for moderate-to-severe plaque psoriasis. In this trial, healthy participants receive different doses of LY4100511 alongside other medications to assess safety, tolerability, and interactions. Specifically, participants in Cohort 1 receive LY4100511 Dose 1 with midazolam and repaglinide, while those in Cohort 2 receive LY4100511 Dose 2 with the same medications. Cohort 3 participants receive LY4100511 Dose 3 with digoxin and rosuvastatin. Early results suggest it could be effective, but more research is needed to confirm its benefits. Overall, LY4100511 remains in the early testing stages, and its full potential is being explored. ^{2 3 4 5 6}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can participate in a study to evaluate how LY4100511 (DC-853) affects the body's processing of certain drugs. Specific eligibility criteria are not provided, but typically participants must be free from any significant health issues.

Inclusion Criteria

I am a woman capable of becoming pregnant.

I am in good health with no significant medical issues.

My BMI is between 18.0 and 32.0, and I weigh at least 50 kg.

Exclusion Criteria

Presence of active suicidal ideation or positive suicide behavior using baseline/screening version of the C-SSRS

My heart's electrical activity is normal and doesn't pose risks for study participation.

I have tested positive for active or latent TB.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4100511 in combination with cytochrome P450 substrates to assess pharmacokinetics and safety

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4100511 (DC-853)

Trial Overview The study is testing the effects of two doses of LY4100511 (DC-853) on how the body breaks down drugs processed by liver enzymes CYP3A4 and CYP2C8. It will compare these effects when LY4100511 is taken alone versus with repaglinide or midazolam.

How Is the Trial Designed?

Group I: LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) Experimental Treatment 3 Interventions

Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin.

Group II: LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) Experimental Treatment 3 Interventions

Participants will receive up to an oral dose 2 of LY4100511 and single dose of midazolam and repaglinide. Dosing will not proceed until a satisfactory review of the safety and tolerability data from lower dose level is performed.

Group III: LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) Experimental Treatment 3 Interventions

Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.

Who Is Running the Clinical Trial?

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Lead Sponsor

Trials

10

Recruited

810+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06602219

NCT06602219 | A Study of LY4100511 (DC-853) in Adult ... The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06345794

A Study to Assess LY4100511 (DC-853) in Healthy Adult ... Study Overview. The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose ...

3. trials.lilly.com trials.lilly.com/en-US/trial/533216

A Study of LY4100511 (DC-853) in Adult Participants With ... The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

4. clinicaltrials.eu clinicaltrials.eu/inn/ly4100511/

Ly4100511 – Application in Therapy and Current Clinical ... These studies aim to evaluate its safety, tolerability, and effectiveness in healthy individuals and patients with specific conditions like plaque psoriasis.

5. delta.larvol.com delta.larvol.com/Products/?ProductId=30b206ad-83d7-45dc-8e97-75fe562df7e1

simepdekinra (LY4100511) / Eli Lilly A study to evaluate safety, tolerability of LY4100511 (DC-853) in healthy Asian and non-Asian participants.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06311656

A Study to Evaluate Safety, Tolerability of LY4100511 (DC- ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... The main purpose of this study is to assess the safety and tolerability of LY4100511 ...