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Disclosure: I consult for Viking Therapeutics and provide research consulting to Novo Nordisk. Full disclosures, including my role at Vineyard, are at the end.
Patients who’ve done well on tirzepatide often ask me the same question: do I have to take this forever? For years, the best evidence I could offer came from withdrawal trials, and in those trials much of the lost weight came back within a year of stopping.
On October 16, Fractyl Health reported pivotal randomized data for an option that isn’t a drug. In REMAIN-1, one endoscopic procedure on the lining of the duodenum, done after tirzepatide stopped, reduced 6-month weight regain compared with a sham procedure. Fractyl’s headline is that Revita patients kept about 80% of their weight loss. The other half of that sentence, the part that shows what the procedure added, is that the sham group kept 67%.
| REMAIN-1 · 6 months after stopping tirzepatide | |||||||||
| On average, both groups kept most of their loss. Revita kept more. | |||||||||
| Modeled share of a 20% tirzepatide weight loss still off at month 6 | |||||||||
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| Model estimates at a 20% reference loss (actual average 18.3%), not the share of patients who kept their weight off. Lighter segment = share regained. Company-reported; not peer reviewed. Refs 1, 2. |
Those percentages are easy to misread. They’re Fractyl’s model estimates of how much of a 20% tirzepatide weight loss would still be off at 6 months. The 20% is a reference value, not the actual average, which was 18.3%. They don’t tell you how many patients kept their weight off. A post hoc analysis comes closer. Among participants with a week-26 weight eligible for the efficacy analysis, 85 of 176 Revita participants (48%) and 22 of 74 sham participants (30%) retained at least 80% of their loss. For comparing the groups, the regain figures under the bars are more direct.