Quit Your GLP-1 Without the Regain: New Revita Data Says it’s Looking More Possible!

Original posted at obesity.news/ on Dec 02, 2025

We love a happy surprise here at OTP, and Fractyl Health just delivered one. The company released 6 month open label data from its REVEAL-1 cohort and the headline writes itself. People who stopped their GLP-1 after losing an average of 24% of their body weight held almost all of it for half a year after a single Revita procedure.

Held as in a mean weight change of only 1.5%. A population that usually regains ~10% by this point barely moved. Investors can nitpick size and design later. This is a signal we simply cannot ignore.

The Setup

REVEAL-1 enrolled 22 people who had already lost at least 15% of their weight on a GLP-1. These were the strong responders, the people who typically rebound fast once therapy stops. Duration on their GLP-1 ranged from 5 months to 5 years. By the time they entered the study, they had dropped an average of 24% of total body weight, more than 50 lbs for many.

Then the GLP-1 stopped. Participants received one Revita procedure. No chronic maintenance. No weekly injections. Nothing but the simple outpatient procedure and follow up.

The Part that Flips the Script on GLP Discontinuation

Instead of the predictable climb back up the scale, weight stayed almost perfectly stable.

• Mean weight change at 6 months: 1.5%

• Expected regain at 6 months after GLP-1 withdrawal from third party studies: ~10%

• HbA1c change: 0.04%, compared to the 0.4% rise seen after GLP-1 withdrawal in the STEP 1 extension

Safety looked clean. No procedure related serious adverse events. Mild issues resolved on their own.

The stability from month 1 to month 3 to month 6 gives Fractyl something rare in obesity maintenance research. A curve that refuses to turn upward.

Why This Matters for the Market

This is the part sponsors and payers care about. Millions of people will eventually cycle off GLP-1s. Some will lose coverage. Some will not tolerate long term therapy. Some will take drug holidays and never return. The field has never had a real answer for what happens next.

For 2 years, I have talked about this exact question with Fractyl CEO Harith Rajagopalan on my podcast. He has been consistent every time. If you fix the gut level nutrient sensing dysfunction that drives metabolic instability, weight maintenance should become more predictable after GLP-1 therapy ends.

Today’s data does not prove the theory, but it pushes it much closer to the center of the conversation.

The Path Forward

Fractyl enters 2026 with momentum.

• REMAIN 1 midpoint data hits in January

• REVEAL 1 one year data arrives in Q2

• REMAIN 1 one year data follows in Q3

• Pivotal 6 month topline and a potential PMA filing target H2

Breakthrough Device designation already puts Revita on the FDA’s radar. Randomized pivotal data will tell us how much of today’s signal survives stricter controls.

The Bottom Line

The REVEAL-1 readout is obviously small. It is open label. But it challenges one of the only outcomes in obesity medicine everyone treats like a guarantee. Weight regain after stopping GLP-1 therapy.

Fractyl just showed a version of what the opposite looks like. 6 months of stability. A flattened curve where a climb has always been expected. If the randomized data even rhymes with this, the off ramp market gets real very fast.

And with what I know from interviewing Harith over the past 2 years, this is not the end of the story. It is the first convincing chapter.

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