LY3537982 for Kidney Problems
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the right dose of LY3537982, an experimental drug, for individuals with kidney issues, particularly severe kidney problems. Participants will take LY3537982 orally, and the study will last about 43 days for each person. The trial includes groups based on kidney function: normal, moderate, and severe impairment. Ideal participants have kidney problems but are not on dialysis and have stable blood pressure. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that up to 2 grams per day of acetaminophen is allowed during the study.
Is there any evidence suggesting that LY3537982 is likely to be safe for humans?
Researchers are currently determining the right dose of LY3537982 for individuals with kidney problems. Detailed safety information about this new treatment remains limited. As the study is in its early stages, the primary focus is on identifying a safe dosage, with safety being closely monitored.
In these early trials, researchers primarily look for side effects to assess how well participants tolerate the treatment. While solid evidence may not yet exist, any serious side effects typically lead to adjustments in the study's conduct.
If LY3537982 receives approval for another condition, it could suggest its safety. However, the current goal is to ensure its safety for individuals with varying levels of kidney function.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for kidney problems, which often include dialysis or medications like ACE inhibitors and ARBs, LY3537982 is unique because it is administered orally and targets different stages of renal function impairment. Researchers are excited about LY3537982 because it offers a potential new way to manage kidney issues by being suitable for patients with normal, moderate, or severe renal impairment. This versatility and method of delivery could make it more convenient and accessible, providing a fresh approach where current options might fall short.
What evidence suggests that LY3537982 might be an effective treatment for kidney problems?
Research is investigating LY3537982 as a potential treatment for serious kidney problems. The trial includes different arms to study the effects of LY3537982 on patients with varying levels of kidney function, including normal renal function, moderate renal impairment, and severe renal impairment. This treatment targets specific aspects of kidney health to aid those with severe kidney issues. While the effectiveness is still under evaluation, early studies are examining its efficacy and optimal dosage. The ongoing research aims to confirm its potential benefits and ensure safety for patients with different levels of kidney impairment.23467
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 adults with moderate to severe kidney problems who have a BMI of 19.0-42.0 kg/m², stable blood pressure, and pulse rate. They must not be on dialysis or have had certain cancers in the last 5 years, no hepatitis B/C or HIV, no known allergies to LY3537982, and agree to contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of LY3537982 to assess pharmacokinetics
Observation
Participants are monitored for pharmacokinetic analysis and safety assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY3537982
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