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Not yet recruitingNCT07883590Updated Oct 20, 2026

A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS).

A Phase 1 interventional study of LY3873862 and CYP450 Drug Cocktail in Amyotrophic Lateral Sclerosis and Cytochrome P-450 Enzyme System, sponsored by Eli Lilly and Company. Not yet recruiting at 4 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
  • Cytochrome P-450 Enzyme System
03

In context

Amyotrophic Lateral Sclerosis

1,000 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 284 are open to participants now.

This study's planned enrollment of 32 is below the median of 37 across 678 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    LY3873862 or Placebo (Cohort 1)

    LY3873862 or placebo administered orally

    Drug: LY3873862 · Drug: Placebo

  • Experimental
    LY3873862 or Placebo (Cohort 2)

    LY3873862 or placebo administered orally with a CYP450 drug cocktail

    Drug: LY3873862 · Drug: CYP450 Drug Cocktail · Drug: Placebo

  • Experimental
    LY3873862 or Placebo (Cohort 3)

    LY3873862 or placebo administered orally with a CYP450 drug cocktail

    Drug: LY3873862 · Drug: CYP450 Drug Cocktail · Drug: Placebo

Interventions

  • DrugLY3873862

    Administered orally

  • DrugCYP450 Drug Cocktail

    CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally.

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  1. Number of Patients with One or More Treatment Emergent Adverse Events Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline, Day 28

Secondary outcomes

  1. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3873862

    Time frame: Baseline, Day 7

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY3873862

    Time frame: Baseline, Day 7

07

Study locations

4 sites
  • Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus
    San Francisco, California 94109, United States
    • · Contact · (415) 600-3604
    • Jonathan Katz · Principal investigator
  • University of Colorado Anschutz
    Aurora, Colorado 80045, United States
    • · Contact · (303) 724-2188
    • Laura Foster · Principal investigator
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    • · Contact · (913) 945-6429
    • Omar Jawdat · Principal investigator
  • McGill University
    Montreal, H4A 3J1, Canada
    • · Contact · (514) 449-8741
    • Angela Genge · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 41 industry-sponsored phase 1 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's planned 12 months is below that.

Counting every sponsor, half of 71 studies reached it within 21 months; a quarter within 14 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2026
First posted
Oct 20, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07883590
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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