Product Details
| Purity |
99%+ |
| Actual peptide content |
Exceed the standard |
| Cleanliness |
Sterile |
| Test Report |
COA HPLC |
| Customized top color |
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| Custom content |
2mg 5mg 10mg 15mg 20mg 30me etc. |
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| Transportation time |
7-15days |
| Disguise |
Can provide |
| Resend policy |
According to different countries |
New evidence suggests new weight loss drugs may also help patients with metabolic dysfunction-associated steatohepatitis (MASH).
The interim study, a randomized, double-blind, placebo-controlled, dose-finding Phase 2 study (NCT04771273), enrolled 295 participants and evaluated Survodutide 2.4 mg, 4.8 mg, and 6.0 mg versus placebo. Efficacy and safety.
The trial's primary endpoint is the percentage of subjects who achieve histological improvement in MASH without worsening of their fibroids at the end of the 48-week treatment period.
To be included in the trial, patients needed to have MASH and stage F1-F3 fibrosis. Notably, the trial included patients with and without type 2 diabetes. For the purposes of this analysis, histologic improvement in MASH was defined as a reduction of 2 points or more in the Nonalcoholic Fatty Liver Disease Activity Score (NAS: total score range 0-8), including a 1-point reduction in the NASH subscore that includes lobular inflammation or ballooning. points or above, and there is no increase in fibrosis stage.
Trial results showed that the use of survodutide was associated with a statistically significant improvement in MASH, with 83.% of patients in the survodutide group achieving histological response compared with 18.2% in the placebo group (response difference, 64.8%; confidence Range 51.1-78.6; P<0.0001).
Improvements in the primary outcome were observed across all doses examined in the trial, and the trial also met all key secondary endpoints, which included a relative reduction in liver fat content of 30% or greater after 48 weeks, improvement in fibrosis, and NAS after 48 weeks Absolute change in total score from initial.
The trial's safety analysis showed no unexpected safety or tolerability issues, including with the 6.0 mg dose. Boehringer said it plans to provide complete data from the trial in the coming months.
According to Boehringer, Survodutide is the first drug to show such efficacy in a mid-stage MASH trial and is expected to become the best treatment for this progressive disease. The disease affects more than 115 million people worldwide and causes inflammation and fibrosis that can lead to liver cancer, liver transplantation and death.
Survodutide (formerly known as BI 456906) is a dual glucagon/GLP-1 receptor agonist that received Fast Track designation from the U.S. Food and Drug Administration in 2021 for the treatment of MASH with fibrosis.
Other GLP-1-targeted drugs for obesity and diabetes are also exploring their potential in MASH, including Novo Nordisk's Ozempic/Wegovy (semaglutide) and Eli Lilly and Company's /Zepbound (tezeparatide). ), both drugs also target GIP, but Boehringer believes that activating two key gut hormone receptors simultaneously may produce a more potent effect than current single hormone agonists. Targeting the receptors that control the hormone glucagon increases the liver's metabolic rate.
If the efficacy of survodutide in MASH is confirmed in pivotal trials, this indication may be added to the drug's label. The drug is currently in Phase 3 trials for obesity, and five Phase 3 trials are underway to test the drug in overweight and obese people. Results from a Phase 2 dose-finding study in overweight and obese patients without type 2 diabetes were presented at the American Diabetes Association Scientific Sessions 2023 and showed that patients administered a 4.8 mg dose of survodutide experienced an average weight loss of 14.9%. More than 65% lost 15% or more of their weight.
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