A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS).
A Phase 1b, Randomized, Placebo-Controlled, Participant and Investigator-Blinded, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Cytochrome P450 Interaction of Orally Administered LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 6 visits
- Time periods mentioned: 13 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "For each participant, the study will last up to approximately 13 weeks and will include 6 clinic visits."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of different doses of LY3873862 in people with ALS, a disease that harms nerves that control muscles. It also measures how much of the drug enters the blood and how long the body takes to clear it. The study lasts up to about 13 weeks and includes 6 clinic visits.
The main purpose of this study in participants with Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS) is to test the safety of different doses and to determine the amount of LY3873862 that gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last up to approximately 13 weeks and will include 6 clinic visits.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have ALS diagnosed by a doctor experienced in treating it, using the study’s diagnosis rules. ALS may run in your family or occur without a family history.
- Have ALS symptoms that started within 24 months before screening.
- Have a body mass index (BMI), a measure based on height and weight, from 18 to 35.
- People assigned male or female at birth may join, whether or not they can have children. Birth control use must follow local rules for clinical studies.
- Be able to safely swallow solid food, liquids, or both.
Who can't join
- Have a health problem, abnormal blood test, or abnormal blood pressure that the study doctor thinks makes joining unsafe.
- Have another disease that causes nerve cells to break down, or serious memory or thinking problems.
- Have a breathing test result below 50% of the expected value.
- Have liver tests above the study’s limits or a kidney filtering test result below 60.
- Take riluzole without a stable dose for more than 30 days before Day 1, or take edaravone without completing 2 treatment cycles before Day 1.
- Take or plan to take tofersen during the study, or take certain medicines that affect how the body breaks down drugs during the study’s restricted time period.
- Have evidence of HIV or hepatitis B, or a positive hepatitis C antibody test. A positive hepatitis C antibody test is allowed only if a follow-up test finds no virus.
- Have serious back pain, back disease, back injury, or an infection where a spinal tap would be done that could make the procedure difficult or unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Have a diagnosis of sporadic or familial Amyotrophic Lateral Sclerosis (ALS) (definite, probable, laboratory probable) made by physician experienced with management of ALS as defined by the World Federation of Neurology revised El Escorial criteria. * Have an ALS symptom onset as determined by the investigator within 24 months of screening. * Have a body mass index within the range 18 to 35 kilograms per square meter (kg/m²) (inclusive). * Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB), including both individuals of childbearing potential (IOCBP) and individuals not of childbearing potential (INOCBP). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Are able to safely swallow solids or liquids, or both. Exclusion Criteria: * Have a history or presence of medical illness that, in the judgment of the investigator, indicates a medical problem that would preclude study participation including, but not limited to cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, neurologic, convulsions, or any clinically significant laboratory abnormality. * Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems at screening. * Have a slow vial capacity (SVC) less than (\<) 50% predicted value (for sex, age, ethnic origin, and height) at screening. * Have significant hepatic abnormalities (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 times (×) upper limit of normal (ULN) or total bilirubin (TBL) \>1.5× ULN, in asymptomatic individuals with a history of Gilbert's syndrome, use TBL of \>2× ULN). * Have a significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per 1.73 square meters (eGFR\<60 mL/min/1.73m²)). * If taking riluzole, must be on a stable dose for more than 30 days (prior to Day 1). * If taking intravenous or oral edaravone, must have completed 2 treatment cycles (prior to Day 1). * Are currently taking or plan to take tofersen for the duration of the study. * Show evidence of Human Immunodeficiency Virus (HIV) and/or positive human HIV antibodies. * Show evidence of hepatitis B and/or positive hepatitis B surface antigen. * Have a positive Hepatitis C Virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV Ribonucleic Acid (RNA) test is negative. * Have an abnormal blood pressure judged to be clinically significant by the investigator. * Have a history of clinically significant back pain, pathological conditions of the back, or back injury (for example, degenerative disease, spinal deformity, or spinal surgery), have a local infection at the intended site of the lumbar puncture (LP) that may predispose to complications or technical difficulty with LP. * Are taking or intend to take inhibitors or inducers of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 from 14 days prior to the first dose of any study intervention, or for 5 half lives (whichever is longer), until the final PK sample is collected.
Study sites (3)
CA
- Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus · San Francisco, CA 94109 · Study contact · (415) 600-3604Jonathan Katz · Principal investigatorMore trials in San Francisco
CO
- University of Colorado Anschutz · Aurora, CO 80045 · Study contact · (303) 724-2188Laura Foster · Principal investigatorMore trials in Aurora
KS
- University of Kansas Medical Center · Kansas City, KS 66160 · Study contact · (913) 945-6429Omar Jawdat · Principal investigatorMore trials in Kansas City