Body Weight Maintenance in Subjects With Obesity Who Have Achieved at Least 15% Weight Loss on Tirzepatide (REMAIN-1)
Sponsor
Fractyl Health Inc.
ClinicalTrials.gov ID
NCT06484114
First the method details:
Midpoint analysis – 3 month follow up
n= 45 (pilot study)
Revita versus sham at 2:1
Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease (“CVD”) risk factors, body composition and pre-diabetes status.
Now the results:
12 of 13 participants maintained or lost weight at 3 months, with 6 of 13 losing additional weight after stopping GLP-1 therapy and undergoing Revita procedure
Median weight remained stable through 3 months (0.46% / ~ 1 pound weight change within the margin of error for daily weight measurement), compared to expected 5–6% weight regain (10–15 pounds) after stopping GLP-1 therapy
Consistent with prior studies of Revita, the procedure was well tolerated, with no unanticipated or serious adverse effects. No new safety concerns were observed.
Post-Revita TBW maintenance data at 3 months were as follows:
| n=13 | Pre-GLP-1Rx Weight (kg) | Post-GLP-1Rx TBW Change (%) | TBW Change 1-month Post-Procedure (%) | TBW Change 3 months Post-Procedure (%) |
| Mean | 104.6 | -23.0 | 0.66 | 0.84 |
| Median | 100.2 | 20.9 | 0.43 | 0.46 |
| IQR | 11.8 | 12.1 | 3.1 | 3.7 |
Why this is important and relevant for investment consideration:
Every GLP-1 weaning trial has shown consistent re-gain of weight w/ cessation of the medication. This has been a major shortcoming of the therapy.
Additionally when compared to gastric surgery, long term CVD outcomes of GLP-1s are worse.
This new minimally invasive (endoscopic) procedure, that is safe and well tolerated and does not permanently alter the anatomical arrangement of the foregut shows durable weight loss potential without the long term use of medication. In clinical practice this is a major area of concern for patients.
Additionally I would be hopeful that like gastric surgery, this minimally invasive alternative could meet the secondary endpoints of long term improved CVD risk.
Endoscopic procedures are a crucial part of medicine today with an advanced roll that is only expanding.
I expect, as long as future study data is consistent, that this will have a big impact on clinical practice.
Readjudication 