We’re neck deep in the 85th annual ADA Scientific Sessions and this one stopped us in our tracks.
Novo Nordisk just dropped data from the STEP-UP trial and it’s the first real look at what happens when you push semaglutide past the 2.4 mg ceiling. Not in a Reddit thread. Not from a compounded vial. In a proper placebo controlled study.
The answer? You get numbers that start to look a whole lot like surgery.
People on 7.2 mg of semaglutide lost an average of 21% of their body weight over 72 weeks. But get this, 33% of them lost 25% or more.
That’s a third of people shedding a quarter of their body weight. No surgery. No sleeve. Just a higher dose of the same molecule already on the market. That’s pretty incredible!
Here’s the side by side:
7.2 mg semaglutide: 21.0% average weight loss
2.4 mg semaglutide: 17.5%
Placebo: 2.4%
And check out this breakdown:
86% lost at least 10%
70% lost at least 15%
51% lost at least 20%
33% lost at least 25%
This wasn’t in people with type 2 diabetes. This was straight obesity treatment. The group who is unfortunately most often told they’re not sick enough to qualify for real help.
Side effects? The usual GLP-1 stuff. Nausea, GI issues, mostly during titration. Dropout rates stayed low, 3.3% on 7.2 mg versus 2.0% on 2.4 mg.
But here’s what matters most. A whole lot of people are stuck on 2.4 mg, doing everything right, and still plateaued in their weight loss. STEP-UP shows that wasn’t a personal failure. It was a dose ceiling. Not a body limit. A system limit.
Novo says they’ll file for a label update in Europe this year, with US submissions coming after. And there’s a second STEP UP trial already underway for people with type 2 diabetes.
This changes everything. If and when 7.2 mg gets approved, we’re going to see a whole new tier of results. And for a lot of us who’ve plateaued, that might be the unlock we’ve been waiting for.
Stay tuned to OnThePen.com for more updates and in depth analysis on the latest developments in weight loss and diabetes treatments. Sharing this article is a powerful form of advocacy that brings us closer to our goal of educating the masses and reducing the stigma of obesity. If you found this article helpful, please share it inside the Facebook groups, the Reddit forums, and anywhere people are talking about GLP-1s.
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Great news that the results have been shared and they are applying to get it approved at the higher dose. Can't wait to hear about the higher dose zepbound trial results (20mg and 25mg dose) I'm a slow responder so I speculate I need a higher dose. Wish I could lose 10 lbs a month..I just lose 1 lb and that's with a lot of hard work.
I figured out why these #s were so high. These are the trial product estimand values (17.5% for 2.4mg and 20.7% for 7.2mg). When you look at the treatment policy estimand you actually get 15.6% and 18.7% respectively. Novo likes to report the higher, rosier #s. Lilly reports the lower. The trial product estimate lets you toss out those who didn’t adhere to the protocol (illness, titration issues, etc).