{"url_path":"/sec/guts/8-k/2026-06-04/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-04","source_url":"https://www.sec.gov/Archives/edgar/data/1572616/0001193125-26-256445-index.html","accession_number":"0001193125-26-256445","cik":"0001572616","ticker":"GUTS","issuer_name":"FRACTYL HEALTH, INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1572616/0001193125-26-256445-index.html","primary_entity_key":"0001572616","primary_entity_name":"FRACTYL HEALTH, INC."},"word_count":386,"has_tables":true,"body_markdown":"## Item 8.01 Other Events.\n\nOn June 4, 2026, the Company announced positive one-year results from its open-label REVEAL-1 Cohort in individuals with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy.\n\n \n\nThe REVEAL-1 data show that patients who underwent a single Revita procedure maintained approximately 78% of their prior GLP-1-induced weight loss at one year, with 33% of patients continuing to lose weight one year after discontinuing a GLP-1.\n\n \n\nKey Findings:\n\n•\nParticipants lost ~24% total body weight (>50 lbs.) on GLP-1 drugs prior to enrollment (duration on GLP-1 therapy ranging from five months to five years.) Patients were enrolled who had lost at least 15% total body weight on GLP-1 medicines, with 17 of 22 participants having greater than 17.5% total body weight loss on GLP-1 drugs. Safety and complete efficacy data through one year are available for 22 and 15 participants, respectively.\n\n•\nParticipants maintained stable weight after a single Revita procedure, with a mean total body weight change of 5.3% ± 2.1% (LS means ± SE; n=15) at one year. An efficacy estimand in the full analysis set demonstrated similar results, with mean total body weight change of 5.8% ± 2.0% (LS means ± SE; n=22). Participants retained ~78% of their drug-induced weight loss at one year. 33% of participants continued to lose weight at one year.\n\n•\n100% of patients in the REVEAL-1 Cohort maintained at least 5% of GLP-1-induced weight loss through one year. This ≥5% threshold is the responder definition used as the second co-primary endpoint in the REMAIN-1 Pivotal Cohort, which evaluates a responder rate among the Revita treated participants at one year to assess the durability of the Revita procedure for weight maintenance after GLP-1 discontinuation.\n\n•\nMinimal change in HbA1c levels was observed after the Revita procedure (0.08% ± 0.08%; LS means ± SE from MMRM; n=15), compared to the ~0.4% increase in HbA1c seen post-GLP-1 discontinuation in the STEP-1 trial extension of GLP-1 withdrawal.\n\n•\nNo procedure-related serious adverse events and no new treatment emergent adverse events were observed. Mild treatment-emergent adverse events occurred in eight of 22 participants (36%), were transient, self-limited, and all occurred within the first month of treatment. No late device-related adverse events were observed."}