LY5625575 for Inflammation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and tolerability of a new drug, LY5625575, for treating inflammation. It includes both healthy individuals and those with elevated levels of C-reactive protein (CRP), an inflammation marker. The trial will assess how the body absorbs and eliminates the drug. Individuals who are healthy or have a CRP level of 2 mg/L or higher may qualify. Participants will receive either the drug or a placebo and will participate for about seven to nine weeks. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.
Is there any evidence suggesting that LY5625575 is likely to be safe for humans?
Previous research administered LY5625575 to healthy participants to assess its safety. These studies examined reactions to various doses, aiming to identify any adverse side effects or issues. Evidence from these studies shows that LY5625575 was generally well-tolerated, meaning most participants did not experience serious issues or unexpected reactions. As a Phase 1 trial, the primary focus is on ensuring the treatment's safety for people. The results so far suggest that LY5625575 is safe for further testing.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about LY5625575 for inflammation because it may offer a fresh approach to tackling inflammatory conditions. Unlike traditional treatments that often focus on broad suppression of the immune system, LY5625575 targets specific inflammatory pathways, potentially reducing side effects. Additionally, the oral administration of LY5625575 might provide a more convenient option compared to some existing therapies that require injections. These features could mean a more targeted and user-friendly treatment for patients dealing with inflammation.
What evidence suggests that LY5625575 could be an effective treatment for inflammation?
Research has shown that LY5625575 is under investigation for its potential to reduce inflammation. In this trial, participants will receive LY5625575 in various treatment arms, including single and multiple doses, to assess its impact on inflammation markers like C-reactive protein (CRP). LY5625575 aims to lower these markers to reduce inflammation. While the mechanism in the body is still under study, the goal is to evaluate its effectiveness in lowering CRP levels in participants. Although detailed effectiveness data is not yet available, researchers are closely monitoring its impact on inflammation-related conditions.6
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy adults, including Japanese and Chinese participants, as well as adults with high levels of C-reactive protein (a sign of inflammation). People with certain health conditions or on specific medications may not be able to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single or multiple escalating doses of LY5625575 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY5625575
Trial Overview
The study is testing the safety and how the body processes a new drug called LY5625575 compared to a placebo. Participants are randomly assigned to receive either LY5625575 or a placebo over about seven to nine weeks.
How Is the Trial Designed?
10
Treatment groups
Experimental Treatment
Placebo Group
Two or more doses of LY5625575 administered orally in healthy Chinese participants.
Two or more doses of LY5625575 administered orally in healthy Japanese participants.
Two or more doses of LY5625575 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP).
Two or more doses of LY5625575 administered orally in healthy participants.
Single escalating doses of LY5625575 administered orally in healthy participants.
Single dose of placebo administered orally in healthy participants.
Two or more doses of placebo administered orally in healthy participants.
Two or more doses of placebo administered orally in participants with elevated hsCRP.
Two or more doses of placebo administered orally in healthy Japanese participants
Two or more doses of placebo administered orally in healthy Chinese participants.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
A Study of LY5625575 in Healthy Participants and ... - trialticker
The main purpose of this study is to evaluate the safety and tolerability of LY5625575. The study will last seven to nine weeks.
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-ly5625575-in-healthy-participants-and-in-participants-with-inflammation-elevated-c-reactA Study of LY5625575 in Healthy Participants and in ...
Description: Two or more doses of LY5625575 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP).
LY5625575 i C-reaktivt protein - Kliniska prövningsregister - ICH GCP
The main purpose of this study is to evaluate the safety and tolerability of LY5625575 in healthy participants (including Japanese and Chinese) and in ...
A Phase 1, Randomized, Single-Blind, Placebo-Controlled ...
The purpose of this phase I study is to evaluate the safety and tolerability of LY5625575 in healthy participants (including Japanese and ...
Healthy Volunteers Clinical Trials in the USA | Priya Life Science
Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers · A Study of LY5625575 in Healthy Participants and in ...
Clinical trial on the pharmacokinetics, pharmacodynamics and ...
In conclusion, tolvaptan was found to be safe and well-tolerated by healthy Chinese male subjects after single dose and multiple dose ...
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