Lilly stops trial of muscle-sparing obesity drug because it's bad business. Others do the same.

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Meritocrat

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The monopolizing, future big Pharma trillionaire tyrant, Lilly just pulled the plug on a trial running bimagrumab. The trial was originally set to end in late 2026 and it was started by small firm, Versanis bio, a startup. Lilly bought versanis two years ago and now ended the trial. Bimagrumab had already shown incredible results with reducing muscle loss to under 10% during long-term fat loss. When it was used alongside a GLP-1 drug, not only did weight loss increase, but so did lean mass.

"The study stoppage comes as the FDA appears to be indicating that drugs like bimagrumab may need to do more than just improve muscle composition.."

Crony capitalism aka plutocracy aka oligarchy at work. Clearly, the plebes aren't meant to enjoy the fruits designed for the Patricians.

Another firm halted testing of their myostatin inhibtor with 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."

It's an actual trend with many other pharmaceutical firms doing the same thing.

https://www.biopharmadive.com/news/lilly-terminate-obesity-trial-bimagrumab-muscle-diabetes/761105/
 
Interesting piece. It’s notable that neither Novo Nordisk or Eli Lilly could figure out how to make money with bimagrumab along with the FDA signaling they may now even approve it. In the end, it’s a business decision.
 
Thanks for posting this interesting piece. I read the articel as well. I don't understand one thing: the FDA statement that “that incremental weight loss” over a GLP-1 drug alone “is an acceptable primary endpoint to support approval.” Doesn't that signal that the FDA will consider approval of muscle mass preservation drugs as a supplement to offset the GLP impact on muscle mass? And therefore isn't that encouragement to continue with the trials? If the pharma companies went this far with their trials, wouldn;t this FDA signal encourage completion of the trials? I must be missing something.
 
This article is over a year old. Lilly may have decided to call it a wash on their 1.8B purchase of Versainis but Veru has shown great results and is now in Phase II trials




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UpDownLeftRightAS* said:


This article is over a year old. Lilly may have decided to call it a wash on their 1.8B purchase of Versainis but Veru has shown great results and is now in Phase II trials View attachment 29232

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Am I reading that right? They just combined a GLP-1 with a SARM? I want to see that study like right now. Did they check to see if it's HPTA suppressive?
 
Meritocrat said:


"The study stoppage comes as the FDA appears to be indicating that drugs like bimagrumab may need to do more than just improve muscle composition.."

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One of the things I found researching this issue is it does not seem that hard to get a drug to show increased muscle mass, but much much harder and very rare to show a demonstrated improvement in muscle performance or improved physical function. This mostly applies to when they are being used to help with sarcopenia from age or disease, and the increases in muscle are only a few percent.

I am not entirely sure it is a relevant issue in the context of reducing muscle loss with glp therapy, where at least some of the benefit is from increased lean mass increasing metabolic rate, helping to maintain long term weight loss. And I find it hard to believe that the large reductions in losses of muscle in this context would not increase physical performance.
 
I think there is a misunderstanding here. They stopped 1 of the studies (NCT06901349, with T2 diabetes patients), but didn't stop the development of bimagrumab all together. The study NCT06643728 (with adipositas , no T2 diabetics) is still running. So it seems they focus on adipositas over diabetes here.
 
I think there is some misunderstanding here. The FDA said something about bimagrumab's muscle-building effects being inconsequential, not worthy enough to look into. It was the Pharma chap who said that it isn't their concern if the endpoint is weight loss alone without bothering about muscle loss. They claimed to be ok with that. Also, using a SARM to preserve muscle is not quite the same as a myostatin inhibitor.
 
I do think these myostatin drugs can have some very serious side effects, and should be approached with a high level of caution. At the same time, I’m hoping one these big pharma companies can atleast get it right, so far its seemed a bit rough though

“The myostatin inhibitor route is interesting too. Seems like a unicorn therapy that a lot of companies have tried to chase (or are chasing) with little success. A lot of the big name companies are plowing R&D money into these, especially in combination with GLP therapies in some of the trials.

- Pfizer tried to develop Domagrozumab which failed in phase 2 from lack of benefits

-Eli Lily developed Landogrozumab which has proven to be inconsistent

-regeneron is developing Trevogrumab which seems to be ongoing

-some company called Wyeth pharmaceuticals developed Stamulumab which had limited efficiency

-a parent company named scholar rock has a drug called Apitegromab which has shown promise in improving motor function in spinal muscle atrophy (how relevant this would be to bodybuilding use? I have no idea)

There’s also receptor/pathway blockers developed or in development like:

- Bimagrumab — which has shown some promise in limited human trials. Who knows what the risks are though

-ACE-031 was developed then halted due to bleeding issues

- KER-065 (Keros Pharma) — which is in early phase trials ; not sure what the data suggests on that yet

Then there’s the myostatin binding protein type drugs like Follistatin or gasp-1 which from my understanding seem to be ineffective and/or have a risky side effect profile

So it does seem like myostatin still might be the next path, they just haven’t gotten quite there yet.
 
Another major risk is that myostatin is basically a growth break. By inhibiting it with a myostatin inhibitor, we remove the growth break.

The assumption here only dreams to be that this applies towards skeletal muscle. It could also very well apply to organs as well? Heart, liver, kidneys, intestines etc.
 
I'm very interested in Apitegromab. Looks like it lowers lean muscle loss when using Tirp by 50%. https://www.nature.com/articles/s41591-026-04440-4

I'm very curious at how it would work with Reta and whether this is a product the chinese could produce. Although being a monoclonal antibody it seems not likely and by the time it is available officially I will probably already have hit my target weight years ago.
 
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