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NCT06297590

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 4 months later.

See at-risk trials from Eli Lilly

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Record History

All 23 versions: 20 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Feb 2027 to Jul 2028
    • Enrollment increased: 48 → 56 participants
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 8 of 8 entries
  2. Site details revised at 2 of 10 sitesv22
  3. Site details revised at 2 of 10 sitesv21
  4. Site contacts updated at 2 of 10 sitesv19
  5. Enrollment target: 32 to 48
    • Site contacts updated at 1 of 10 sites
    v18
Show 14 earlier versionsHide 14 earlier versions
  1. Site details revised at 2 of 10 sitesv16
  2. Secondary endpoints revised (8)
    • Site contacts updated at 1 of 10 sites
    • Eligibility criteria shortened, about 4 words
    v15
  3. Site details revised at 3 of 10 sitesv14
  4. Site contacts updated at 1 of 10 sitesv13
  5. Study sites: 12 to 10v12
  6. Site details revised at 1 of 12 sitesv10
  7. Site details revised at 1 of 12 sitesv9
  8. Site details revised at 2 of 12 sitesv8
  9. Site details revised at 2 of 12 sitesv7
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2024 to Aug 15, 2024
    • Study sites revised (12)
    v6
  11. Study sites: 11 to 12v5
  12. Enrollment target: 60 to 32v4 Show 4 more changesShow less
    • Start date: Jun 2024 to Jul 2024
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 5 of 8 entries
    • Study sites revised (11)
  13. Start date: Apr 8, 2024 to Jun 2024
    • Study sites: 8 to 11
    • Primary and study completion dates: Feb 27, 2027 to Feb 2027
    v3
  14. Study Status, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Timeframe: Baseline up to Week 36 and Week 72 (for optional bridging period participants)
Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Timeframe: Baseline up to Week 76

Secondary (8)

Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Part B: PK: Cmax
Part A: PK: Area Under the Concentration Versus Time Curve (AUC)
Part B: PK: AUC
Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068
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Part B: PK: CSF concentration of LY3954068
Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau
Part B: PD: Change from Baseline of CSF tau

Arms and interventions

LY3954068 (Part A)Experimental

Single ascending dose of LY3954068 administered intrathecally (IT)

Placebo (Part A)Placebo comparator

Single ascending dose of placebo administered IT

LY3954068 (Part B)Experimental

Multiple ascending dose of LY3954068 administered IT

Placebo (Part B)Placebo comparator

Multiple ascending dose of placebo administered IT

Drugs: LY3954068, Placebo, Flortaucipir F18

Sites

10 sites in 3 countries

United States 6, United Kingdom 3, Japan 1