LY3848575 for Healthy Subjects

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

Disqualifiers: Other clinical study participation

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 20 weeks

64 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking medications might affect eligibility.

What data supports the effectiveness of the drug LY3848575?

Research shows that blocking the action of epiregulin, a component of LY3848575, can inhibit tumor growth in certain cancer cells. This suggests that LY3848575 might be effective in targeting similar pathways in other conditions. ^{1 2 3 4 5}

How is the drug LY3848575 different from other treatments?

LY3848575 is unique because it targets epiregulin, a member of the epidermal growth factor family, which is involved in cell growth and cancer progression. Unlike other treatments that may block the entire EGFR pathway, LY3848575 specifically neutralizes epiregulin, potentially reducing side effects like skin toxicity associated with broader EGFR inhibition. ^{1 3 4 6 7}

What is the purpose of this trial?

This trial is testing a new drug called LY3848575 to see if it is safe and well-tolerated. The study includes healthy non-Japanese and first-generation Japanese participants. Researchers will check how fast the drug gets into the blood and how long it stays in the body.

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

Eligibility Criteria

This trial is for healthy adults who weigh at least 50 kg (110 lbs) for males, 40 kg (88 lbs) for females, and have a BMI of 18-30. Japanese participants must be first-generation with all parents and grandparents born in Japan. Participants can't join if they're in another study or were in one within the last 3 months.

Inclusion Criteria

I weigh at least 50kg if male, 40kg if female, and my BMI is between 18-30.

Participants who are overtly healthy as determined by medical evaluation

I am of first-generation Japanese descent, with all my parents and grandparents born in Japan.

Exclusion Criteria

Have participated, within the last 3 months, in a clinical study involving an IP.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive single ascending or multiple doses of LY3848575 administered either intravenously or subcutaneously

Approximately 20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3848575

Trial Overview The study tests LY3848575 given by IV or under the skin to see how safe it is and how the body handles it. It compares this new drug to a placebo over roughly five months, including screening time before starting.

Participant Groups

Group I: LY3848575 SC Experimental Treatment 1 Intervention

Multiple doses of LY3848575 administered subcutaneously (SC).

Group II: LY3848575 IV Experimental Treatment 1 Intervention

Single ascending doses of LY3848575 administered intravenously (IV).

Group III: Placebo SC Placebo Group 1 Intervention

Placebo administered SC.

Group IV: Placebo IV Placebo Group 1 Intervention

Placebo administered IV.

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Anti-EGFR monoclonal antibodies which act as EGF, TGF alpha, HB-EGF and BTC antagonists block the binding of epiregulin to EGFR-expressing tumours. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Prognostic role of ERBB2, MET and VEGFA expression in metastatic colorectal cancer patients treated with anti-EGFR antibodies. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Structural basis of selectivity and neutralizing activity of a TGFα/epiregulin specific antibody. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Distribution of mRNA for human epiregulin, a differentially expressed member of the epidermal growth factor family. [2019]

5. England pubmed.ncbi.nlm.nih.gov

An antibody to amphiregulin, an abundant growth factor in patients' fluids, inhibits ovarian tumors. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Epiregulin Recognition Mechanisms by Anti-epiregulin Antibody 9E5: STRUCTURAL, FUNCTIONAL, AND MOLECULAR DYNAMICS SIMULATION ANALYSES. [2021]

7. England pubmed.ncbi.nlm.nih.gov

First-in-human, dose-escalation, phase 1 study of anti-angiopoietin-2 LY3127804 as monotherapy and in combination with ramucirumab in patients with advanced solid tumours. [2023]