LY4064809 + Esomeprazole for Healthy Adults

Overseen By This is a single site clinical trial 1-877-CTLilly (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Disqualifiers: Metabolic, Biliary, GI, Neurological, 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 tests the safety of a new drug, LY4064809, and examines how food and a common heartburn medication, esomeprazole (a proton pump inhibitor), affect its performance in the body. Researchers aim to determine if eating or taking esomeprazole alters the effectiveness of LY4064809. Healthy adults not taking any medication and without significant medical conditions might be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for 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 coordinator or your doctor.

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

A previous study tested LY4064809 with other drugs to evaluate its efficacy and safety. More than 10% of patients experienced common side effects, such as changes in hemoglobin levels. Serious side effects, like fluid around the lungs, were less common, occurring in about 1.2% of patients.

Esomeprazole, often used for stomach issues, can cause common side effects like headaches and nausea, which may be reduced by taking the medication with food.

Overall, studies have shown that LY4064809 and esomeprazole have manageable side effects. Serious reactions occur less frequently. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LY4064809 combined with esomeprazole because it offers a novel approach to proton pump inhibitor (PPI) therapy. Unlike standard PPIs that mainly focus on reducing stomach acid, LY4064809 is being examined for its potential to enhance the effect of esomeprazole, possibly leading to improved efficacy in managing gastric acidity. This combination could offer quicker relief and better symptom control for conditions requiring acid suppression, providing a new option for those who may not respond adequately to current treatments.

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

Research has shown that LY4064809 is under study to determine if it can enhance the effectiveness of other cancer treatments. Earlier studies used LY4064809 with other cancer drugs to evaluate its safety and impact on cancer cells. In this trial, some participants will receive LY4064809 alone, while others will receive it with esomeprazole, a drug that reduces stomach acid, to assess its effect on the body's processing of LY4064809. Early results suggest that understanding the interaction between these two drugs might improve treatment outcomes. ^{1 5 6 7 8}

Who Is on the Research Team?

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. It's not clear who can't join because the exclusion criteria are missing, but typically people with certain health conditions or taking conflicting medications would be excluded.

Inclusion Criteria

Participants must have a body mass index (BMI) within the range 18-32 kilogram/square meter (kg/m²) (inclusive)

I am not capable of becoming pregnant or I was assigned male at birth.

My blood pressure and pulse rate are within normal ranges.

Exclusion Criteria

I have not had major surgery in the last 30 days.

I have a history of blood disorders.

I have or had a stomach or intestine disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive LY4064809 under different conditions: fasted, with a high-fat meal, and with esomeprazole

6 weeks

Multiple visits for blood tests and drug administration

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Esomeprazole

Trial Overview The study is testing LY4064809 to see how food and esomeprazole (a stomach acid reducer) affect its safety and how it's processed by the body. Participants will take the drug with and without food, and their blood will be tested.

How Is the Trial Designed?

Group I: Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect Experimental Treatment 1 Intervention

LY4064809 administered orally with esomeprazole

Group II: Group 2 Treatment A Fasted Experimental Treatment 1 Intervention

LY4064809 administered orally

Group III: Group 1 Treatment B High-Fat Meal Experimental Treatment 1 Intervention

LY4064809 administered orally

Group IV: Group 1 Treatment A Fasted Experimental Treatment 1 Intervention

LY4064809 administered orally

Who Is Running the Clinical Trial?

Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07174336

A Study of LY4064809 With Other Anti-Cancer Treatments ... The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for ...

2. delta.larvol.com delta.larvol.com/NewsItem/NewsItemID/7c7c20bd-f3ae-4963-b39c-f9da6130bfb3/A+Study+of+Food+Effect+and+Esomeprazole+on+LY4064809+in+Healthy+Adult+Participants

A Study of Food Effect and Esomeprazole on LY4064809 in ... The age groups are: Child (birth-17); Adult (18-64); Older Adult (65+) ... A measure of all deaths, due to any cause, that occur during a clinical study. ... A ...

3. withpower.com withpower.com/trial/phase-3-breast-neoplasms-9-2025-cab27

LY4064809 for Breast Cancer · Info for Participants The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced ...

4. prnewswire.com prnewswire.com/news-releases/lilly-to-present-new-clinical-data-for-verzenio-abemaciclib-and-multiple-novel-pipeline-programs-at-the-2025-european-society-for-medical-oncology-esmo-annual-meeting-302581179.html

Lilly to present new clinical data for Verzenio (abemaciclib ... In a late-breaking oral presentation, Lilly will share updated results from the Phase 1/2 PIKALO-1 trial, a study of LY4064809 ... outcomes for ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/breast-cancer

UCSF Breast Cancer Clinical Trials — San Francisco Bay ... The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast ...

6. fidelity.com fidelity.com/news/article/default/202510130645PR_NEWS_USPR_____DE95319

Lilly to present new clinical data for Verzenio (abemaciclib ... The most common adverse reactions (incidence ≥10%), including laboratory abnormalities, in patients who received Inluriyo were: hemoglobin ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-food-effect-and-esomeprazole-on-ly4064809-in-healthy-adult-participants

A Study of Food Effect and Esomeprazole on LY4064809 in ... The purpose of this study is to evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton ...

8. lillyoncologypipeline.com lillyoncologypipeline.com/molecule/pan-mutant-selective-pi3kapha/

Pan-Mutant Selective PI3Kα Inhibitor Molecule Overview LY4064809 (STX-478) is a mutant-selective, allosteric PI3Kα inhibitor. It has shown preclinical activity in PI3Kα kinase and helical domain mutant driven ...