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NCT05463731

A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

StatusCompleted
PhasePhase 3
Primary completion
Track this trial

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Record History

All 39 versions: 33 with changes below, 6 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 2026 to May 12, 2026
    v39
  2. Primary completion date: Jun 6, 2024 to Apr 24, 2024v36
  3. Study completion date: Mar 31, 2026 to Mar 2026v33
  4. Enrollment target: estimated 600 to confirmed 1667
    • Eligibility criteria shortened, about 44 words
    • Study description expanded, about 1 word
    v32
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Oct 1, 2025 to Jun 6, 2024
    • Study completion date: Oct 1, 2026 to Mar 31, 2026
    • Site details revised at 76 of 76 sites
    v31
Show 27 earlier versionsHide 27 earlier versions
  1. Site details revised at 1 of 76 sitesv30
  2. Study sites: 69 to 76v29
  3. Study sites: 76 to 69v28
  4. Study sites: 74 to 76v27
  5. Primary completion date: Oct 2025 to Oct 1, 2025
    • Study completion date: Oct 2026 to Oct 1, 2026
    • Site contacts updated at 1 of 74 sites
    v26
  6. Study sites: 75 to 74v25
  7. Study sites: 76 to 75v24
  8. Site contacts updated at 2 of 76 sitesv22
  9. Site details revised at 2 of 76 sitesv21
  10. Primary completion date: Feb 1, 2025 to Oct 2025
    • Study completion date: Feb 1, 2026 to Oct 2026
    v20
  11. Primary completion date: Mar 28, 2024 to Feb 1, 2025
    • Study completion date: Mar 27, 2025 to Feb 1, 2026
    • Site contacts updated at 4 of 76 sites
    v18
  12. Study sites revised (76)v17
  13. Site contacts updated at 1 of 76 sitesv16
  14. Study sites revised (76)v15
  15. Enrollment target: 400 to 600
    • Study description expanded, about 18 words
    • Study arms: 4 to 5
    v14
  16. Site contacts updated at 2 of 76 sitesv13
  17. Study sites: 77 to 76v12
  18. Site details revised at 1 of 77 sitesv11
  19. Site details revised at 2 of 77 sitesv10
  20. Study description revised
    • Site details revised at 4 of 77 sites
    v9
  21. Study sites: 78 to 77v8
  22. Study sites: 76 to 78
    • Primary completion date: Aug 5, 2024 to Mar 28, 2024
    • Study completion date: Nov 15, 2025 to Mar 27, 2025
    v7
  23. Study sites: 75 to 76v6
  24. Study sites: 71 to 75v5
  25. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 71 of 71 sites
    v4
  26. Study sites: 59 to 71v3
  27. Study Status, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Timeframe: Week 52

Secondary (5)

Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo
Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)

Arms and interventions

Remternetug (IV)Experimental

Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.

Remternetug (SC)Experimental

Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.

PlaceboPlacebo comparator

Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.

Open-Label Addenda Remternetug (IV)Experimental

Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda.

Open-Label Addenda Remternetug (SC)Experimental

Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.

Drugs: Remternetug (IV), Remternetug (SC), Placebo

Sites

76 sites in 2 countries

United States 73, Japan 3