Olomorasib for Healthy Participants

Recruiting at 1 trial location

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Any medication

Disqualifiers: Females childbearing, Drug allergy, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10 days

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, olomorasib, to understand its movement through the body and duration of presence. Participants will take olomorasib orally and stay overnight at the research center for 10 consecutive days. The trial includes three groups, each trying a different version of olomorasib to compare their effects. It seeks healthy individuals without chronic diseases who are not currently using any medication. 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 your current medications at least 14 days before joining the trial, except for occasional acetaminophen (up to 2 grams per day).

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

Research shows that olomorasib is under investigation as a potential treatment for certain types of cancer. It targets a specific mutation called KRAS G12C, often found in some lung cancers. Although olomorasib remains in the early stages of testing, it has received Breakthrough Therapy Designation from the FDA, indicating promising results in early studies.

Detailed safety information about olomorasib is limited. However, its testing in humans means it has passed initial safety checks in lab and animal studies. Early trials focus heavily on safety, so researchers closely monitor participants for any side effects. If olomorasib had severe side effects, it likely wouldn't have reached this stage.

Overall, while more information is needed, olomorasib is considered safe enough for human testing. Researchers will carefully monitor trial participants to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Olomorasib is unique because it offers multiple formulations that could potentially improve efficacy and patient experience compared to current treatments. While most standard therapies for various conditions rely on single formulations, Olomorasib includes both test and reference formulations, allowing researchers to explore which might offer the best outcomes. This flexibility could lead to more personalized treatment options and optimize how the drug is absorbed in the body. Researchers are excited about Olomorasib because it may provide a more tailored approach, offering different ways to achieve better results with fewer side effects.

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

Research has shown that olomorasib holds promise for treating certain cancers. Studies found that, when used alone, it helped 35% of patients with non-colorectal cancer solid tumors. Specifically, in patients with the KRAS G12C mutation, olomorasib effectively treated lung cancer. Combined with pembrolizumab, it benefited 74% of patients with this mutation. These findings suggest olomorasib could be effective for these cancer types.

In this trial, healthy participants will receive different formulations of olomorasib to evaluate its safety and pharmacokinetics. ^{1 6 7 8 9}

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 trial is for healthy individuals who can commit to a study period of about 7 weeks, including 10 consecutive overnight stays at the research center. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Body mass index (BMI) between 18.0 to 30.0 kilograms per square meter (kg/m²), inclusive

I cannot become pregnant or get someone pregnant.

I am generally healthy with no significant ongoing illnesses.

Exclusion Criteria

I am currently breastfeeding or able to become pregnant.

Clinically significant history of any drug sensitivity, drug allergy, or food allergy

I haven't used any medication recently, except for occasional small doses of acetaminophen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive multiple formulations of Olomorasib orally over 10 back-to-back overnight stays

10 days

10 overnight stays (in-person)

Follow-up

Participants are monitored for pharmacokinetics and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Olomorasib

Trial Overview The trial is testing olomorasib capsules taken orally by healthy participants. It aims to assess how much of the drug enters the bloodstream and the duration it remains in the body before being eliminated.

How Is the Trial Designed?

Group I: Olomorasib - (Test Formulation 2) Experimental Treatment 1 Intervention

Olomorasib administered orally

Group II: Olomorasib - (Test Formulation 1) Experimental Treatment 1 Intervention

Olomorasib administered orally

Group III: Olomorasib - (Reference Formulation) Active Control 1 Intervention

Olomorasib 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/NCT07044271

A Study of Multiple Olomorasib (LY3537982) Capsules in ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. investor.lilly.com investor.lilly.com/node/50826/pdf

Updated Data from the Phase 1/2 Study of Olomorasib in ... Efficacy for olomorasib monotherapy was consistent across a range of solid tumors with an ORR of 35% (37/105) in patients with non-CRC solid.

3. prnewswire.com prnewswire.com/news-releases/updated-data-from-the-phase-12-study-of-olomorasib-in-kras-g12c-mutant-advanced-solid-tumors-presented-at-the-2024-asco-annual-meeting-302160829.html

Updated Data from the Phase 1/2 Study of Olomorasib in ... Data demonstrated promising monotherapy activity with olomorasib across a range of KRAS G12C-mutant solid tumors, including non-small cell lung cancer.

4. asco.org asco.org/abstracts-presentations/ABSTRACT482740

Efficacy and safety of olomorasib, a second-generation ... Olomorasib + cetuximab demonstrated similar antitumor activity and favorable safety at both dose levels in pts with KRAS G12C-mutant CRC.

5. onclive.com onclive.com/view/olomorasib-plus-pembrolizumab-earns-breakthrough-therapy-designation-in-untreated-kras-g12c-mutated-nsclc

Olomorasib Plus Pembrolizumab Earns Breakthrough ... Olomorasib combined with pembrolizumab shows high efficacy in KRAS G12C-mutant NSCLC, with a 74% overall response rate and 91% disease control ...

6. selleckchem.com selleckchem.com/products/olomorasib.html

olomorasib | Ras inhibitor | Mechanism | Concentration Olomorasib (KRAS G12C inhibitor 19, LY3537982) is a potent and highly selective second-generation inhibitor of GDP-bound KRAS G12C, with the potential.

7. targetedonc.com targetedonc.com/view/fda-grants-breakthrough-therapy-designation-to-olomorasib-in-kras-g12c-nsclc

FDA Grants Breakthrough Therapy Designation to ... FDA designates olomorasib and pembrolizumab as breakthrough therapy for advanced KRAS G12C-mutant lung cancer, showing promising response ...

8. trials.lilly.com trials.lilly.com/en-US/trial/585993

Study of Olomorasib (LY3537982) in Combination ... - Lilly Trials The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination.

9. prnewswire.com prnewswire.com/news-releases/lillys-olomorasib-receives-us-fdas-breakthrough-therapy-designation-for-the-treatment-of-certain-newly-diagnosed-metastatic-kras-g12c-mutant-lung-cancers-302545643.html

Lilly's olomorasib receives U.S. FDA's Breakthrough ... LOXO-RAS-20001 is an open-label, multicenter, Phase 1/2 study evaluating the safety, tolerability and preliminary efficacy of olomorasib in ...