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/
 
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/
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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.
 
Reta Ed said:

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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I'm in the same boat.

Every so often I pull up the ERP list hoping to spot Apitegromab. 🙂
 
Sector said:

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.
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Pretty much the same story as Anabolic's... Sure, you build muscle, but depending on which compound is picked (even when the sides are managed), the side effect profile can still be harmful to the body. For men in particular: an enlarged heart and prostate. I'd guess GH could produce the same outcome through systemic growth overall?
 
deleted.user.32 said:


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/

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One possible route to approval, in my view, is showing added weight loss on top of the primary weight loss drug when a weight loss drug is paired with a muscle preserving drug. According to the FDA, sparing muscle by itself does not clear the bar. In my opinion, more evidence is needed — for instance, demonstrating that patients on the muscle sparing weight loss medicine combination end up healthier, function better physically, or are able to produce greater force through their muscles; a smaller amount of muscle loss on its own cannot justify using the combination.
 
Almost every trial involving compounds that build muscle mass — whatever the class — keeps coming up short when it comes to measurable day-to-day function of those bigger muscles, things such as 6 minute walk time or handgrip strength. Why this occurs is something I doubt anyone truly understands, yet the pattern repeats across most studies, whether the population is older adults, people with cancer-related sarcopenia, patients with various muscular dystrophies, or subjects taking a muscle preserving agent alongside GLP drugs. The specific drug and its mechanism appear to matter little: testosterone, sarms, growth hormone, growth hormone stimulating drugs, myostatin inhibitors — all raise muscle mass, and none has ever won approval as a therapy for that indication, because none demonstrates meaningful, significant gains in real world performance of the muscle. (I am fairly sure that high dose test or AAS or high dose HGH probably does increase strength at least if exercise is done, otherwise a lot of bodybuilders are wasting their time, but at lower safer doses it is more doubtful)

One could make the case that when obesity is treated with GLP drugs, simply holding onto the mass for metabolic reasons may be worth something regardless. The low dose embosarm study with semaglutide struck me as very promising. How much benefit in term of energy expenditure actually comes from those extra kilos of retained muscle is a bit questionable. Oddly, GLP drugs improve muscle quality and relative strength even while they reduce muscle mass, in part by cutting fat within the muscle tissue. And in spite of the muscle loss, GLP drugs do deliver real world performance and functional improvements — perhaps not absolute strength, but anything weight related like getting up from the floor or a chair or walking or going up stairs improves a lot.
 
I looked into this further, and the program seems to still be moving ahead.

Below is a chronological breakdown of how bimagrumab has developed, following it from the acquisition through to where it stands clinically today and what lies ahead:

2023: Acquisition & Early Promise

  • July 2023: Versanis Bio is bought by Eli Lilly for as much as $1.92 billion, giving Lilly formal rights to bimagrumab. The plan is to combine it with Lilly's already-marketed incretin drugs in order to address lean muscle loss that occurs while weight is being reduced.

Early 2026: Breakthrough Results & Primary Data

  • Early 2026: Full findings from the pivotal Phase 2 BELIEVE trial appear in Nature Medicine. According to the data, combining bimagrumab with semaglutide produces a very large 22.1% total body weight loss, and an unprecedented 92% of that loss coming strictly from fat instead of muscle.
  • April 30, 2026: The Phase 2 trial (NCT06643728) that is still running, which tests bimagrumab together with tirzepatide (Zepbound) in adults who are non-diabetic, overweight, or obese, arrives at its Primary Completion date. The main weight management data is now locked for analysis.

Mid-to-Late 2026: Pipeline Reshaping (Current Status)

  • Mid-2026: A separate Phase 2b trial (NCT06901349), which had been studying the bimagrumab/tirzepatide pairing specifically in patients with obesity and type 2 diabetes, is officially cancelled by Eli Lilly. The company says the stop stems from strategic business positioning rather than any safety issue.
  • October 2026 (Present): For Lilly, bimagrumab is still an active asset and a high priority. Its development path has been narrowed so that general obesity is targeted first, removing the complications of the diabetic sub-population in order to get a quicker route to the FDA.

2027 and Beyond: Future Milestones

  • January 31, 2027: The Estimated Study Completion date is reached by the active Phase 2 non-diabetic trial (NCT06643728).
  • Early 2027: Analysis and public release of the full data readouts from this trial are expected. For Eli Lilly, this data will act as the final "go/no-go" signal.
  • Beyond 2027: Should the data come back positive, Lilly is expected to move bimagrumab into Phase 3 global registration trials and to actively pursue reformulation of the drug from an intravenous (IV) infusion into a patient-friendly subcutaneous injection for commercial launch.
 
Strategic Outlook

In the injectable category, the field has essentially come down to 2 frontrunners: Eli Lilly (bimagrumab) and Regeneron (trevogrumab). Meanwhile, Veru (enobosarm) sits at the front of the oral tablet pipeline. When it comes to raw fat-burning power — the 92% fat-to-muscle ratio — Eli Lilly's bimagrumab is still among the very strongest assets out there, yet it has to keep a close eye on how quickly Regeneron's clinical trials are advancing.
 
The price is still going to be out of reach, since both myostatin inhibitors are antibodies, and I really doubt that Chinese peptide manufacturers will start gearing up to make antibody-based therapeutics, given how much more it costs and how much more complex they are to produce. So unfortunately it is unlikely to ever show up as a grey option. As far as I know, there are no small molecule myostatin inhibitors in human trials. That means they will probably cost at least as much as tirzepatide, and maybe more, at $5k-15+ a year.

Enobosarm, also called Ostarine or MK-2866, is available right now, but only as 25mg pills, or as a variant called ostarine-ac, an acetylated form that changes its pharmacokinetics (and maybe other properties too). There is very little information out there about it, which is a shame because it is easy to find on ebay. Veru, the company studying it, is also working on a modified version of ostarine, but I cannot determine exactly what has been modified or whether it is the same thing as ostarine-ac. Still, they sound confident about moving forward with development, and phase 2b and 3 trials are planned or already underway. From what I was able to learn, it can cause liver toxicity like many other SARMs, though not frequently and possibly not at all at low doses such as the 3mg they intend to trial. At this point it is the closest thing to a human tested muscle sparing agent that can actually be obtained, showed minimal muscle loss when combined with semaglutide, and is probably non toxic at low doses, though I would not be confident at all about higher doses, and getting accurate doses from 25mg pills is not exactly straightforward, even if the pill dose itself is accurate.
 
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