Amyotrophic Lateral SclerosisPhase 1NCT07883590
A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS).
A Phase 1 study testing LY3873862 and CYP450 Drug Cocktail in people with Amyotrophic Lateral Sclerosis and Cytochrome P-450 Enzyme System, run by Eli Lilly and Company at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Cytochrome P-450 Enzyme System
- What is being tested?
- LY3873862 and CYP450 Drug Cocktail
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2026to Nov 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
4 sites in 2 countries
United States3 sites
University of Colorado Anschutz
Aurora, Colorado, 80045
(303) 724-2188
Laura Foster
University of Kansas Medical Center
Kansas City, Kansas, 66160
(913) 945-6429
Omar Jawdat
Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus
San Francisco, California, 94109
(415) 600-3604
Jonathan Katz
About this study
Official title: 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
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.
- Being tested
- LY3873862, CYP450 Drug Cocktail, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3873862Drug
Administered orally
CYP450 Drug CocktailDrug
CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally.
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3873862 or Placebo (Cohort 1) | Experimental | LY3873862 or placebo administered orally Receives: Drug: LY3873862; Drug: Placebo |
| LY3873862 or Placebo (Cohort 2) | Experimental | LY3873862 or placebo administered orally with a CYP450 drug cocktail Receives: Drug: LY3873862; Drug: CYP450 Drug Cocktail; Drug: Placebo |
| LY3873862 or Placebo (Cohort 3) | Experimental | LY3873862 or placebo administered orally with a CYP450 drug cocktail Receives: Drug: LY3873862; Drug: CYP450 Drug Cocktail; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with One or More Treatment Emergent Adverse Events Considered by the Investigator to be Related to Study Drug Administration
Measured: Baseline, Day 28
Secondary outcomes (2)
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3873862
Measured: Baseline, Day 7
Pharmacokinetics: Maximum Concentration (Cmax) of LY3873862
Measured: Baseline, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883590
- Sponsor's protocol ID
- 27886
- Other IDs
- J3X-MC-LYGD
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No