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NCT07883590Not yet recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
32 (estimated)
First submitted
14 Oct 2026
Start date
1 Nov 2026
Primary completion date
30 Nov 2027
Lead sponsor
Eli Lilly and Company
NCT number
NCT07883590

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 32
  • From 1 Nov 2026 to the primary completion date, 30 Nov 2027
  • 4 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems at screening.
  • 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 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.

Lab values

  • 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 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)).

Age

  • Have a slow vial capacity (SVC) less than (\<) 50% predicted value (for sex, age, ethnic origin, and height) at screening.

Other

  • Have an abnormal blood pressure judged to be clinically significant by the investigator.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McGill University
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
University of Colorado Anschutz
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.