Fractyl的Revita关键研究达主要终点 停用GLP-1后保持八成减重成果
马萨诸塞州伯灵顿讯——Fractyl Health（纳斯达克：GUTS）10月16日经GlobeNewswire公布REMAIN-1关键队列六个月数据。该研究共纳入308名受试者，为多中心、随机、双盲、假手术对照试验：受试者先在导入期使用替尔泊肽，平均约25周减重18.3%，停用GLP-1药物后按2:1随机接受Revita治疗或假手术。研究达到六个月共同主要终点（p=0.0023，改良意向治疗人群）：Revita组保持了80%的GLP-1减重成果，假手术组为67%；体重反弹幅度分别为5.1%和8.2%。试验未出现与器械或手术相关的严重不良事件。
事后分析显示，Revita组32%的患者体重保持稳定或进一步下降，假手术组为18%（名义p=0.020）；接受单次完整十二指肠消融（20厘米及以上）的亚组体重反弹仅3.8%，假手术组为8.2%。另一共同主要终点在12个月时评估，一年期顶线数据预计2027年第一季度公布。
Revita已获FDA突破性医疗器械认定，用于停用GLP-1后的体重维持；公司计划2026年第四季度末提交De Novo上市申请，其专用CPT代码1122T将于2027年1月1日生效，美国市场潜在上市时间为2028年初。首席执行官Harith Rajagopalan在公告中表示，该结果支持Revita作为停药后维持减重的治疗方案继续推进。
Fractyl's Revita Meets Pivotal Endpoint, Preserving 80% of GLP-1 Weight Loss
BURLINGTON, Mass. — Fractyl Health (Nasdaq: GUTS) on October 16 reported six-month results from the pivotal cohort of its REMAIN-1 study via GlobeNewswire. The multicenter, randomized, double-blind, sham-controlled trial enrolled 308 participants who first took tirzepatide in a run-in period — losing an average of 18.3% of body weight over about 25 weeks — then discontinued the GLP-1 drug and were randomized 2:1 to Revita or sham. The study met its six-month co-primary endpoint (p=0.0023, modified intent-to-treat): Revita patients retained 80% of their GLP-1-induced weight loss versus 67% for sham, with weight regain of 5.1% versus 8.2%. No device- or procedure-related serious adverse events were reported.
In a post hoc analysis, 32% of Revita patients remained weight-stable or lost further weight versus 18% of sham patients (nominal p=0.020); the subgroup receiving a single complete duodenal ablation of at least 20 cm regained 3.8% versus 8.2% for sham. The second co-primary endpoint is at 12 months, with one-year topline data expected in the first quarter of 2027.
Revita holds FDA Breakthrough Device Designation for post-GLP-1 weight maintenance. Fractyl plans to submit a De Novo marketing application in late Q4 2026, a dedicated CPT code (1122T) takes effect January 1, 2027, and a potential U.S. launch is targeted for early 2028. Chief Executive Harith Rajagopalan said in the release that the results support Revita as an endoscopic treatment for weight maintenance after GLP-1 discontinuation.
发布：GSM·美国（发布链接）
图片来源：Fractyl Health公司官方标志 / Fractyl Health official logo
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