secwatch.observer — SEC 8-K summary
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Issuer:     Trevi Therapeutics, Inc. (TRVI)
CIK:        0001563880
Form:       8-K
Filed at:   2024-12-12T23:59:59+00:00
Accession:  0000950170-24-135602
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Trevi Therapeutics reports positive SSRE for Phase 2b CORAL trial; sample size unchanged at 160 patients.
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- SSRE analysis on highest 108mg BID dose after 80 patients completed 6 weeks recommended continuing as planned; no sample size increase or futility.
- Trial enrollment 75% complete; topline results from CORAL Phase 2b still expected in first half of 2025.
- Pre-specified conditional power maintained at 80% or greater based on SSRE outcome.
- Other two pre-specified SSRE outcomes (sample size increase or futility) were ruled out.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563880/000095017024135602/0000950170-24-135602-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563880/000095017024135602/trvi-20241212.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-135602

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer