LY3839840 for Healthy Participants

No longer recruiting at 2 trial locations

Overseen By Nicholas Siebers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Prescription medications

Disqualifiers: Allergies, Infections, Cardiovascular, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new oral medication, LY3839840, by observing how the body processes it at different doses. As a first-in-human study, researchers focus on how the body handles the drug and any potential side effects. Healthy participants who are not taking medications, have not had recent surgeries or infections, and do not have significant medical histories are ideal candidates. Different groups in the trial will receive varying doses, with some participants specifically of Chinese or Japanese descent. 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 any prescription or nonprescription medications at least 14 days before the study starts, or longer if the medication takes more time to leave your body.

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

Research shows that LY3839840 is being tested for safety in healthy people for the first time. This means little information exists about how well people can handle it. As an early study, the main goal is to observe how the body processes the drug and identify any side effects.

In similar cases, researchers closely monitor new treatments for unwanted or harmful effects. Since this study is just beginning, limited safety data is available. However, early trials ensure participants are closely monitored and protected.

For those considering joining this trial, it's important to know that the aim is to learn about the drug's safety and how it works in the body. Researchers usually monitor participants carefully to catch any potential problems early on. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

LY3839840 is unique because it is being tested as a new oral medication with both single and multiple ascending doses, potentially offering a novel option for conditions where current treatments might be limited. Researchers are excited about LY3839840 due to its different approach in delivering the drug orally, which could improve patient compliance and convenience compared to injectable options. Additionally, the inclusion of diverse population groups, like Japanese and Chinese participants, aims to understand its effectiveness and safety across different genetic backgrounds, making it a promising candidate for more personalized medicine.

What evidence suggests that LY3839840 could be effective?

Research has shown that LY3839840 is related to a natural substance in the body that helps control inflammation. Early studies examined how the drug is processed in the body, using healthy participants to determine if it can be safely administered in different amounts. In this trial, participants will receive LY3839840 in various dosing regimens, including single and multiple ascending doses, to further assess its safety and pharmacokinetics. Specific information on its effectiveness for a particular condition is not yet available, as testing remains in the early stages. Further studies will help determine LY3839840's potential for treating diseases. ^{2 3 6 7 8}

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 adults with good venous access for blood sampling. Specific parts require first-generation Chinese or Japanese descent, as defined by the participant's ancestry. Participants must have a BMI of >18 to ≤35 kg/m² (18-29 kg/m² for certain parts), normal vital signs and lab results, agree to contraceptive requirements, and not be pregnant.

Inclusion Criteria

For Part C: Participants must be first-generation Chinese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Chinese descent and born in China.

My BMI is between 18 and 35.

I am a man who agrees to use contraception, or I am a woman who cannot become pregnant.

Exclusion Criteria

Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

I have taken, or plan to take, medication within the last 14 days or 5 half-lives, whichever is longer.

I have signs of active or latent tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single or multiple ascending doses of LY3839840 or placebo, and midazolam in Part E

7-8 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-3 weeks

Follow-up visits for safety assessments

What Are the Treatments Tested in This Trial?

Interventions

• LY3839840

Trial Overview The study tests LY3839840 against a placebo in healthy individuals to assess its safety at various doses and understand how it's processed by the body. It involves giving single and multiple doses of LY3839840 or a placebo.

How Is the Trial Designed?

Group I: Midazolam (Part E) Experimental Treatment 2 Interventions

Midazolam substrate alone or with LY3839840 administered orally

Group II: LY3839840 (Part D) Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally in Japanese participants.

Group III: LY3839840 (Part C) Experimental Treatment 1 Intervention

Single and multiple dose of LY3839840 administered orally in Chinese participants.

Group IV: LY3839840 (Part B) Optional Cohort 5 Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally pending data from Cohort 4

Group V: LY3839840 (Part B) Cohort 4 Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally.

Group VI: LY3839840 (Part B) Cohort 1-3 Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally.

Group VII: LY3839840 (Part A) Experimental Treatment 1 Intervention

Single ascending dose of LY3839840 administered orally.

Group VIII: Placebo (Parts A-D) Placebo Group 1 Intervention

Placebo administered orally.

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. sciencedirect.com sciencedirect.com/science/article/pii/S0031699725075052

Resolution Pharmacology: state-of-the-art and therapeutic ... In terms of clinical trials, the itaconate derivative termed SIT-011 or LY3839840 has been tested in healthy volunteers. The trial (NCT06153355) ...

2. synapse.patsnap.com synapse.patsnap.com/drug/3cc647e0f2ff4b7ca3ef03b30d8d0862

LY-3839840 - Drug Targets, Indications, Patents Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3839840 Following Oral Dosing in Healthy Participants.

3. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=23777464

Fortrea Clinical Research Unit Trials NCT06153355: A First-In-Human Study of LY3839840 in Healthy Participants. Completed. 1. 140. US. LY3839840, Placebo, Midazolam. Eli Lilly and Company. Healthy.

4. trials.lilly.com trials.lilly.com/en-US/find/completed

Completed Trials - Lilly Trials The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants ...

5. docs.publicnow.com docs.publicnow.com/viewDoc.aspx?filename=33758%5CEXT%5C734CFE066D2163E229B5FBCEFF9DFF0F36C550D8_2F26B389520A35B8A78B718793567725BE1FD0F4.PDF

eli lilly and company Healthy. A First-In-Human Study of LY3839840 in Healthy. Participants. 1. 160. Number of participants with one or more Adverse Event. (s) (AEs) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06153355

A First-In-Human Study of LY3839840 in Healthy Participants The main purpose of this first-in-human study to investigate the safety of LY3839840 in single and multiple doses, and how it's processed in the body when given ...

7. trial.medpath.com trial.medpath.com/clinical-trial/c736ecc5df0ad42a/nct06297590-safety-tolerability-pharmacokinetics-ly3954068-alzheimers-disease

A First-In-Human Study of LY3954068 in Participants With ... The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD).

8. insights.citeline.com insights.citeline.com/in-vivo/market-intelligence/the-future-of-inflammation-the-inflammasome-and-beyond-JL3UJUJNGRGGNL2VCEBU2MUWEU/

The Future Of Inflammation: The Inflammasome And Beyond Novel targets for managing inflammation hold the promise of greater efficacy and safety for diseases not widely viewed as inflammatory in nature.