LY3985297 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By Ahad Sabet

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Infections, Surgery, Allergies, Tuberculosis, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether the new drug, LY3985297, is safe and well-tolerated in healthy individuals. Participants will receive the drug either through an IV (into a vein) or under the skin, and the study will measure how the drug moves through the body. It consists of two parts, each testing different dose levels. Healthy individuals with no recent infections or major surgeries, and who have normal vital signs and lab results, are suitable candidates. This includes first-generation Japanese or Chinese participants for certain groups. 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?

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 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 this trial's treatments are likely to be safe?

Research shows that LY3985297 is being tested for safety and tolerability. This Phase 1 trial involves collecting early information from healthy participants. The main goal is to observe how the body reacts to the drug and identify any side effects.

Detailed safety results for LY3985297 are not yet available, as studies are ongoing. However, Phase 1 trials typically aim to identify immediate safety issues and common side effects. Although this trial involves healthy volunteers, results from similar past trials can offer some insights. If the drug has been approved for other uses before, it often suggests general safety, but LY3985297 remains under evaluation.

In summary, while detailed safety data for LY3985297 is not yet available, Phase 1 trials usually indicate low significant risks. Participants are closely monitored for any side effects during these early trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

LY3985297 is unique because it is designed to be administered in both single and multiple ascending doses, either intravenously (IV) or subcutaneously (SC), allowing for flexibility in delivery. This approach is being explored for its potential to improve the drug's absorption and patient convenience compared to standard oral medications. Researchers are excited about LY3985297 because it targets specific pathways, which might offer enhanced efficacy or reduced side effects compared to existing treatments. Additionally, the inclusion of diverse participant cohorts, including Japanese and Chinese individuals, suggests a focus on understanding how different populations respond to the treatment, which could lead to more personalized and effective care options.

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

Research on LY3985297 remains in the early stages, so limited information exists about its effectiveness for specific conditions. This study aims to assess the drug's safety in healthy individuals. Participants will receive either a single ascending dose, multiple ascending doses of LY3985297, or a placebo. The study also examines how the drug moves through the body and how the body eliminates it. Although specific results on effectiveness are not yet available, the goal is to gather crucial safety and dosage information. This will aid future studies that may test its efficacy for certain illnesses. ^{1 2 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 individuals who can participate in a study testing LY3985297. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.

Inclusion Criteria

Participants must be overtly healthy, as determined by medical evaluation

Must have a body mass index of 18.0 to 32.0 kg/m², inclusive, and a minimum body weight of 45.0 kg

Must have venous access sufficient to allow for blood sampling

Exclusion Criteria

Must not have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food

I haven't had any major surgery in the last 12 weeks and don't plan to during the study.

I do not have active or latent tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single ascending dose of LY3985297 or placebo administered either intravenously (IV) or subcutaneously (SC)

12 weeks

Treatment Part B

Participants receive multiple ascending doses of LY3985297 or placebo administered either intravenously (IV) or subcutaneously (SC)

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3985297

Trial Overview The trial tests the safety and tolerability of LY3985297 when given as a single or multiple doses via IV or subcutaneous injection to healthy people. It's split into two parts, assessing how the body absorbs and eliminates the drug.

How Is the Trial Designed?

Group I: Part B: LY3985297 (Cohorts 1-4) Experimental Treatment 1 Intervention

Multiple ascending dose of LY3985297 administered either IV or SC.

Group II: Part A: LY3985297 (Cohorts 1-8) Experimental Treatment 1 Intervention

Single ascending dose of LY3985297 administered either intravenously (IV) or subcutaneously (SC). Cohort 5,6 and 7 is conducted in Japanese or Chinese participants.

Group III: Placebo Comparator: Part A and B: Placebo Placebo Group 1 Intervention

Placebo administered either IV or SC.

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/NCT06395012

A First-In-Human Study of LY3985297 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. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-4-2024-059e5

LY3985297 for Healthy Subjects · Info for Participants The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either ...

3. tipranks.com tipranks.com/news/company-announcements/eli-lillys-ly3985297-study-update-a-potential-game-changer

Eli Lilly's LY3985297 Study Update: A Potential Game ... The study aims to assess the safety, tolerability, and pharmacokinetics of LY3985297, a new drug administered either intravenously or subcutaneously, in ...

4. ctv.veeva.com ctv.veeva.com/study/a-first-in-human-study-of-ly3985297-in-healthy-participants

A First-In-Human Study of LY3985297 in Healthy Participants The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses.

5. clinconnect.io clinconnect.io/trials/NCT06395012

A First-In-Human Study of LY3985297 in Healthy - ClinConnect The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either ...

6. synapse.patsnap.com synapse.patsnap.com/drug/0f206e8572a343bc81692fe8677cac49

LY-3985297 - Drug Targets, Indications, Patents ... Safety, Tolerability, and Pharmacokinetics of LY3985297 in Healthy Participants. 100 Clinical Results associated with LY-3985297. Login to view more data. 100 ...

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06395012/

Trial | NCT06395012 The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either ...

8. tipranks.com tipranks.com/news/company-announcements/eli-lillys-phase-1-study-of-ly3985297-key-insights-for-investors

Eli Lilly's Phase 1 Study of LY3985297: Key Insights for ... ' The study aimed to assess the safety, tolerability, and pharmacokinetics of LY3985297 when administered as single or multiple doses in healthy ...