Eli Lilly has axed a Phase IIb obesity clinical trial involving its blockbuster weight loss and type 2 diabetes (T2D) drug glucagon-like peptide-1 receptor agonist (GLP-1RA) in combination with an investigational muscle-sparing drug.
The study (NCT06901349), which was evaluating a combination of tirzepatide, marketed as Zepbound in obesity, plus investigational muscle-wasting preventor bimagrumab in patients with obesity and T2D, was discontinued due to “strategic business reasons”.
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When asked for details on the termination, a Lilly spokesperson told Clinical Trials Arena: “We routinely evaluate our clinical development programmes to optimise the potential for each product.”
Though the company has chosen to cancel this trial, a corresponding study evaluating Lilly’s Zepbound and bimagrumab in patients with obesity alone will continue. Results from this trial are set to debut in 2026.
Muscle wastage is a common adverse event (AE) associated with GLP-1RA drugs, with other companies investigating the efficacy of myostatin inhibitors as a treatment.
The termination of Lilly’s Phase IIb study involving bimagrumab comes two years after the US pharma took ownership of the drug, which it absorbed through its acquisition of the drug’s licensee, Versanis Bio.
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By GlobalDataThough the activin receptor type-2B (ActRIIB) inhibitor was originally developed by Novartis and MorphoSys to treat pathological muscle loss, it was passed on by the pair after it flunked a Phase IIb/III trial in sporadic inclusion body myositis.
Despite the drug’s jaded past, Versanis saw potential in bimagrumab – reviving clinical development efforts on the drug after buying the rights to it for $70m in 2021.
However, instead of taking it down its previous path, the biotech approached the drug’s development from a new angle, hoping that bimagrumab could prevent muscle loss in obese patients taking medications such as Zepbound.
Through this push to get the drug to market, Versanis initiated the 2023 Phase IIb BELIEVE study, which assessed the efficacy and safety of bimagrumab in combination with Novo Nordisk’s Wegovy (semaglutide) – a staunch competitor of Lilly’s Zepbound.
It appears that Versanis’ belief in the combination was not out of place, as results presented at the 85th Scientific Session of the American Diabetes Association (ADA) revealed that bimagrumab plus Wegovy could trigger fat loss and improve muscle retention better than either treatment alone.
As the results of the BELIEVE trial were positive, the future could be bright for the Zepbound-bimagrumab combination, as Lilly’s star weight loss drug works through a similar mechanism.
Moving forward, analysts at GlobalData, parent company of Clinical Trials Arena, forecast that the obesity market will reach $173.5bn by 2031 across the seven major markets (7MM: (the US, France, Germany, Italy, Spain, the UK and Japan).
This is 1,552% higher than the sector’s 2021 sales, which sit at $10.5bn.
