Lilly Kills a Muscle-Sparing Obesity Trial as Bad Business. Others Follow Suit.

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Meritocrat

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Lilly — that monopolizing, future big Pharma trillionaire tyrant — has just pulled the plug on a trial running bimagrumab. It was a small firm, Versanis bio, a startup, that originally launched the study, with an end date set for late 2026, and Lilly bought versanis two years ago before ending it. Bimagrumab had already turned in incredible results, holding muscle loss to under 10% through long-term fat loss. Stacked with a GLP-1 drug, it raised weight loss and lean mass both.

The report puts it this way: the FDA appears to be signalling that a drug like bimagrumab may have to do more than merely improve muscle composition..

Crony capitalism — plutocracy, oligarchy — at work. Plainly the plebes aren't supposed to enjoy the fruits meant for the Patricians.

A second company stopped testing its myostatin inhibtor alongside GLP's. "Veru earlier this week said the agency “now guides that incremental weight loss” over a GLP-1 drug alone “is an acceptable primary endpoint to support approval.” Veru’s shares fell 3% on Tuesday following that announcement, and another 3% Thursday."

This is a genuine pattern, with plenty of other pharmaceutical firms following the same path.

https://www.biopharmadive.com/news/lilly-terminate-obesity-trial-bimagrumab-muscle-diabetes/761105/
 
Interesting piece. It's notable that neither Novo Nordisk nor Eli Lilly could work out how to make money from bimagrumab, particularly with the FDA signalling they might now approve it. In the end, it comes down to a business decision.
 
Thanks for sharing this interesting piece. I read the article too. One thing I can't follow: the FDA statement that “that incremental weight loss” over a GLP-1 drug alone “is an acceptable primary endpoint to support approval.” Surely that signals the FDA would look favourably on muscle preservation drugs as a way of offsetting GLP-driven muscle loss? Which would be a reason to keep the trials going, no? Having got this far with them, wouldn't that signal from the FDA push the companies toward completing the trials? I must be missing something.
 
That article is more than a year old now. Lilly may have written off their 1.8B purchase of Versainis, but Veru has posted strong results and is now in Phase II trials

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UpDownLeftRightAS* said:

That article is more than a year old now. Lilly may have written off their 1.8B purchase of Versainis, but Veru has posted strong results and is now in Phase II trials

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Have I got that right? A GLP-1 paired with a SARM? I want to see that paper like right now. Did anyone check whether it suppresses the HPTA?
 
Meritocrat said:

Lilly — that monopolizing, future big Pharma trillionaire tyrant — has just pulled the plug on a trial running bimagrumab. It was a small firm, Versanis bio, a startup, that originally launched the study, with an end date set for late 2026, and Lilly bought versanis two years ago before ending it. Bimagrumab had already turned in incredible results, holding muscle loss to under 10% through long-term fat loss. Stacked with a GLP-1 drug, it raised weight loss and lean mass both.

The report puts it this way: the FDA appears to be signalling that a drug like bimagrumab may have to do more than merely improve muscle composition..

Crony capitalism — plutocracy, oligarchy — at work. Plainly the plebes aren't supposed to enjoy the fruits meant for the Patricians.

A second company stopped testing its myostatin inhibtor alongside GLP's. "Veru earlier this week said the agency “now guides that incremental weight loss” over a GLP-1 drug alone “is an acceptable primary endpoint to support approval.” Veru’s shares fell 3% on Tuesday following that announcement, and another 3% Thursday."

This is a genuine pattern, with plenty of other pharmaceutical firms following the same path.

https://www.biopharmadive.com/news/lilly-terminate-obesity-trial-bimagrumab-muscle-diabetes/761105/
Click to expand...
Something I came across while researching this: getting a drug to demonstrate extra muscle mass doesn't look all that difficult, whereas showing a genuine improvement in muscle performance or physical function is far harder and very rarely achieved. That mostly concerns use against sarcopenia from age or disease, and even then the muscle gains amount to only a few percent.

Whether it even matters when the aim is limiting muscle loss on glp therapy is another question, since at least part of the benefit there comes from added lean mass lifting metabolic rate, which helps keep weight off long term. And I struggle to believe that big reductions in muscle losses in this setting wouldn't translate into better physical performance.
 
I think there's a mix-up here. It was 1 of the studies that got stopped (NCT06901349, T2 diabetes patients), not the whole bimagrumab programme. NCT06643728 (adipositas, no T2 diabetics) is still going. So the emphasis seems to be shifting towards adipositas rather than diabetes.
 
There seems to be some confusion on this. What the FDA signalled was that bimagrumab's muscle-building effects looked inconsequential — not worth chasing. The claim that the endpoint can be weight loss alone, muscle loss ignored, and that they're fine with it, came from the Pharma chap. Separately, preserving muscle with a SARM isn't really the same thing as a myostatin inhibitor.
 
These myostatin drugs strike me as capable of some very serious side effects, and they deserve a high level of caution. Even so, I hope one of the big pharma outfits manages to get it right — so far it's all looked a bit rough

The myostatin inhibitor route is interesting too. It reads like a unicorn therapy, chased (or still being chased) by plenty of companies without much to show for it. Loads of the big names keep pouring R&D money in, often in combination with GLP therapies in certain trials.

- Domagrozumab was Pfizer's attempt; it flopped in phase 2 for want of benefit

-Eli Lily and Landogrozumab, which has come out inconsistent

-regeneron has Trevogrumab in development, apparently still ongoing

-Wyeth pharmaceuticals, a company I know only by name, developed Stamulumab with limited efficiency

-scholar rock, a parent company, has Apitegromab, which has looked promising for motor function in spinal muscle atrophy (relevance to bodybuilding use? no idea)

Then come the receptor/pathway blockers, whether already developed or still in the works:

- Bimagrumab — some promise in limited human trials. What the risks really are, nobody knows

-ACE-031 got developed and then shelved over bleeding issues

- KER-065 (Keros Pharma) — early phase trials ; who knows what the data says yet

And then the myostatin binding protein class — Follistatin, gasp-1 — which as far as I can tell are either ineffective, or carry a dangerous side effect profile

So myostatin may well be where things head next; the industry just isn’t there yet.
 
One more major risk: myostatin functions essentially as a growth brake. Block it with a myostatin inhibitor, and that brake comes off.

The hopeful assumption is that skeletal muscle is all this touches. But could it not apply to organs just as readily? Heart, liver, kidneys, intestines etc.
 
Apitegromab interests me a lot. It appears to cut lean muscle loss by 50% while on Tirp. https://www.nature.com/articles/s41591-026-04440-4

What I really want to know is how it behaves alongside Reta, and whether the chinese could manufacture it. Being a monoclonal antibody, probably not — and by the time it's officially on the market I'll likely have been at my goal weight for years.
 
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