LY3857210 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: Implants, Claustrophobia, MRI findings, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the new drug, LY3857210, appears in the brain using a PET scan. It also assesses the drug's safety and tolerability in healthy individuals. Participants will take a single dose of the drug and visit the study center several times over six weeks. Those who are generally healthy and have no issues with MRI scans (such as certain implants or claustrophobia) may be suitable candidates. 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 this trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants, it's possible that you may need to avoid certain medications. Please check with the study team for specific guidance.

Is there any evidence suggesting that LY3857210 is likely to be safe for humans?

Research has shown that LY3857210 has been tested for safety in other studies. In these studies, which included individuals with diabetic nerve pain and osteoarthritis pain, no serious side effects were reported, suggesting that the treatment is generally well-tolerated.

Since the current study is in its early phase, it focuses on safety and tolerability. Researchers are closely monitoring how participants respond to the treatment. Although detailed results from this study are not yet available, previous findings offer some reassurance about the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LY3857210 is unique because it introduces a novel approach by being administered as a single oral dose. Unlike standard treatments that often involve more frequent dosing or different delivery methods, this simplicity could enhance patient compliance. Researchers are excited about LY3857210 because its innovative design might offer quicker or more convenient results compared to existing therapies.

What evidence suggests that LY3857210 might be an effective treatment?

Research has shown that LY3857210, the investigational treatment in this trial, could be a promising option for pain management. In studies on diabetic nerve pain, LY3857210, a non-opioid, proved more effective than a placebo, particularly in reducing severe pain. The drug blocks specific signals that cause pain, as supported by lab and animal studies suggesting its potential to relieve pain. Although further research is needed to confirm these results in humans, early findings are encouraging. ^{1 2 4 5 6}

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?

Inclusion Criteria

Overtly healthy male or female participants as determined by medical evaluation

Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive)

You are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of LY3857210 and undergo PET scans to measure brain receptor occupancy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

Up to 3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LY3857210

How Is the Trial Designed?

Group I: LY3857210 Experimental Treatment 1 Intervention

Single doses of LY3857210 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/NCT05620576

Study Details | NCT05620576 | A Chronic Pain Master ... This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05620563

Study Details | NCT05620563 | A Chronic Pain Master ... The main purpose of this study is to evaluate the efficacy and safety of LY3857210 in participants with Osteoarthritic Pain.

3. ctv.veeva.com ctv.veeva.com/study/a-chronic-pain-master-protocol-cpmp-a-study-of-ly3857210-in-participants-with-diabetic-peripheral

A Study of LY3857210 in Participants With Diabetic Peripheral ... This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/lexicons-non-opioid-therapy-for-dpnp-beats-placebo-in-pain-reduction/

Lexicon's non-opioid therapy for DPNP beats placebo in ... Lexicon Pharmaceuticals' non-opioid-based therapy has outperformed placebo in 10mg doses in patients with severe diabetic peripheral neuropathic pain (DPNP).

5. sciencedirect.com sciencedirect.com/science/article/pii/S1526590025006078

AK1780, a selective P2X7 receptor antagonist with high ... This article presents in vitro and in vivo data for AK1780 (LY3857210), a selective P2X7R antagonist. The data reasonably explain its analgesic effect in ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/painreform-first-part-prf-110-study/

PainReform reports safety results from first part of PRF-110 ... Initial data showed a solid safety profile of PRF-110 with no serious adverse events among the patients. PainReform CEO Ilan Hadar said: “We are ...