The clinical-stage metabolic therapeutics company said the latest findings reinforce Revita’s potential as a durable procedural therapy for weight maintenance after discontinuing GLP-1 treatment
Revita Demonstrates Durable Weight Maintenance
In the modified intention-to-treat population of 45 participants, Revita reduced weight regain by about 40% versus the sham procedure after one year
Patients treated with Revita experienced a least-squares mean weight regain of 7.8% of body weight compared with 13.0% in the sham group
The company said patients who underwent more extensive duodenal ablation, defined as treatment exceeding 14 centimeters, retained about 81% of their GLP-1-induced weight loss after one year
Weight regain in this subgroup was 4.8% versus 13.0% in the sham arm, representing a reduction of more than 60%
Greater Benefit Seen In Higher-Risk Patients
The company also highlighted results from an optimized subgroup consisting of patients who received complete duodenal ablation and had achieved at least 17.5% weight loss during the GLP-1 run-in period
In that group, Revita preserved approximately 84% of GLP-1-induced weight loss at one year, compared with 46% in the sham arm. Least-squares mean weight regain was 4.1% for Revita recipients versus 13.5% for sham-treated participants
According to Fractyl, the findings suggest patients with a greater likelihood of regaining weight after stopping GLP-1 therapy may derive the greatest benefit from Revita
Responder Rate And Safety Profile
The company said 73% of patients in the Midpoint Cohort’s modified intention-to-treat population met the weight-maintenance responder threshold, which measures the proportion of patients maintaining at least 5% total body weight loss relative to their pre-tirzepatide weight after one year
Among participants receiving complete duodenal ablation, the responder rate increased to 91%
Fractyl also reported no device- or procedure-related serious adverse events during the study. No new device-related treatment-emergent adverse events were recorded between six and 12 months
Overall treatment-emergent adverse event rates remained comparable between the Revita and sham groups at 24% and 25%, respectively
The company added that one participant in the sham arm received a new diagnosis of Type 2 diabetes, while no new cases were reported among Revita-treated patients
GUTS Price Action: Fractyl Health shares were up 19.54% at $0.85 at the time of publication on Wednesday
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