First-of-a-kind trial holds promise for obesity and pre-diabetes treatment
Posted: 20 August 2024 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The treatment reduces the risk of progression to type 2 diabetes and supports long-term maintenance of weight loss in adults with pre-diabetes and obesity or who are overweight, data indicates.
Eli Lilly and Company has released positive topline data from the longest completed trial of tirzepatide (Zepbound® and Mounjaro®) to date.
The GIP and GLP-1 receptor agonist was evaluated over 176-weeks compared to placebo in adults with pre-diabetes and obesity or overweight. The aim of the study was to assess its efficacy and safety for long-term weight management and for delaying the participants progression to diabetes.
In the Phase III SURMOUNT-1 study, participants were given once-weekly tirzepatide injections (5mg, 10mg, 15mg). Tirzepatide was further investigated in a 17-week off-treatment period.
Potential as a long-term obesity and pre-diabetes treatment
“Tirzepatide reduced the risk of developing type 2 diabetes by 94 percent”
“Tirzepatide reduced the risk of developing type 2 diabetes by 94 percent and resulted in sustained weight loss over the three-year treatment period. These data reinforce the potential clinical benefits of long-term therapy for people living with obesity and pre-diabetes,” stated Dr Jeff Emmick, PhD, Senior Vice President, Product Development, Eli Lilly.
Overall, tirzepatide facilitated a 22.9 percent decrease in body weight on average at end of treatment with the 15mg dose. In contrast, this decrease was 2.1 percent for placebo at the end of the treatment period.
Primary analysis at 72 weeks for the Phase III trial were published in the New England Journal of Medicine in 2022. Eli Lilly confirmed that the new data for the trial will be submitted to a journal and presented at ObesityWeek 2024.
Investing in tirzepatide
In May this year, the company announced a $5.3 billion investment, topping the largest manufacturing investment in [Eli Lilly’s] history. David Ricks, CEO of Eli Lilly highlighted that it “represents the single largest investment in synthetic medicine API manufacturing in US history.” Expansion of its manufacturing site in Lebanon, Indiana, US, will expand capacity of active pharmaceutical ingredients (APIs) for Zepbound and Mounjaro injections. Eli Lilly and Company stated that medicine production at the Lebanon, US site will begin towards the end of 2026.
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Big Pharma, Clinical Development, Clinical Trials, Drug Development, Drug Safety, Research & Development (R&D), Technology, Therapeutics
