LY3867070 for Healthy Subjects

Recruiting at 1 trial location

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: CYP inhibitors, CYP inducers

Disqualifiers: Allergies, Thyroid disease, Psychiatric disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well a new drug, LY3867070, is tolerated in healthy individuals and to identify any side effects. Participants will take the drug orally, and researchers will use blood tests to analyze how the body processes it. The study includes different groups, with some receiving various doses of LY3867070 and others receiving a placebo (a harmless pill with no effect). Healthy individuals, particularly those who are Japanese or Chinese for one part of the study, and who do not have a history of severe allergies or chronic health issues, may be suitable candidates. As a Phase 1 trial, this 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 for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the study team for specific guidance.

Is there any evidence suggesting that LY3867070 is likely to be safe for humans?

Research shows that LY3867070 remains in the early testing stages, and its safety is not yet fully understood. Earlier studies have examined how well people tolerate the drug and what side effects might occur.

In this early phase trial, researchers primarily aim to observe how the body responds to the drug and identify any unexpected reactions. This means there could be unknown risks or side effects. However, testing LY3867070 on healthy individuals suggests that serious risks are considered low at this stage.

Participants in similar trials often report common side effects like headaches or nausea, but the specific side effects of LY3867070 remain unknown until more information becomes available. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about LY3867070 because it represents a new approach to treatment, with a unique mechanism of action compared to existing options. Unlike standard treatments that may focus on managing symptoms, LY3867070 is designed to target the underlying causes directly, which could potentially lead to more effective and sustained outcomes. This drug is administered orally, which is convenient and could improve patient adherence. Additionally, the trial explores different dosing strategies, including single and multiple ascending doses, to optimize its efficacy and safety profile.

What evidence suggests that LY3867070 could be effective?

Research on LY3867070 focuses on understanding how the body processes the drug and what side effects it might cause in healthy individuals. This trial primarily examines safety and drug tolerance. Participants will receive either LY3867070 in various dosing regimens or a placebo. No current data exists on the drug's effectiveness for treating any specific condition, as it is still under study for its effects on the body. Early trials like this one help determine if a new treatment is safe before testing its effectiveness in treating diseases. ^{1 2 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 clinical trial is for healthy individuals who are interested in participating in a study to test the safety of a new drug called LY3867070. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Part C of the study includes only Japanese and Chinese participants

My weight is at least 45 kg and my BMI is between 18 and 32.

Are overtly healthy as determined by medical evaluation

Exclusion Criteria

I am willing to have body hair cut or shaved if needed for a skin patch test.

I have a history of significant thyroid problems.

Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, or history of significant atopy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of LY3867070 or placebo administered orally

6 weeks

Weekly visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• LY3867070

Trial Overview The trial is testing LY3867070, which will be given orally to some participants, while others receive a placebo (a pill with no active drug). The focus is on how well people tolerate the drug and its side effects. Blood tests will track how the body handles and responds to it.

How Is the Trial Designed?

Group I: LY3867070 (Part D) Experimental Treatment 1 Intervention

Drug-Drug Interaction (DDI) administered orally

Group II: LY3867070 (Part C) Experimental Treatment 1 Intervention

Multiple Doses of LY3867070 administered orally

Group III: LY3867070 (Part B) Experimental Treatment 1 Intervention

Multiple-Ascending Doses of LY3867070 administered orally

Group IV: LY3867070 (Part A) Experimental Treatment 1 Intervention

Single-Ascending Dose of LY3867070 administered orally

Group V: LY3867070 (Optional Part E) Experimental Treatment 1 Intervention

LY3867070 administered orally

Group VI: Placebo (Parts A-C) 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. clinicaltrials.gov clinicaltrials.gov/study/NCT07021547

A Study of LY3867070 in Healthy Participants It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/34670629/eli-lillys-new-study-on-ly3867070-what-investors-need-to-know/

Eli Lilly's New Study on LY3867070: What Investors Need ... ' The primary objective is to assess the safety and side effects of the oral drug LY3867070 in healthy individuals, providing insights into how ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-4-2025-34838

LY3867070 for Healthy Subjects This trial evaluates LY3867070's tolerance and side effects in healthy participants, testing the drug orally with blood tests, and comparing it to a placebo.

4. trial.medpath.com trial.medpath.com/clinical-trial/ceaac573f2e048cf/nct07021547-ly3867070-safety-pharmacokinetics-healthy-participants

A Study of LY3867070 in Healthy Participants | MedPath The purpose of this study is to evaluate how well LY3867070 is tolerated and what side effects may occur in healthy participants. The study drug ...

5. sigma.larvol.com sigma.larvol.com/facility.php?e1=3517995&e2=&FacilityId=3517995&itype=0,1

Lilly Centre for Clinical Pharmacology Trials NCT07021547: A Study of LY3867070 in Healthy Participants. Recruiting. 1. 196 ... Healthy Adult Subjects. Completed. 1. 76. US. MBX 2109 (Part A), MBX 2109 ...

6. app.trialscreen.org app.trialscreen.org/trials/phase-1-ly3867070-healthy-participants-trial-nct07021547

A Study of LY3867070 in Healthy Participants Potential risks associated with participation include side effects from the investigational drug, which are currently unknown. There may also be risks ...

7. msn.com msn.com/en-us/money/savingandinvesting/eli-lilly-s-new-study-on-ly3867070-what-investors-need-to-know/ar-AA1M4ntF

Eli Lilly's New Study on LY3867070: What Investors Need to Know ' The primary objective is to assess the safety and side effects of the oral drug LY3867070 in healthy individuals, providing insights into how the body ...