Biophytis unveils design for obesity study
The trial will enroll 164 overweight or obese patients already treated with GLP-1 weight-loss drugs, to whom 350 mg of its BIO101 (20-hydroxyecdysone) will be administered for 21 weeks.
The company believes that its BIO101 could help preserve muscle function in obese patients treated for weight loss with GLP-1.
The primary efficacy endpoint is to be muscle strength measured by knee extension, with a six-minute walking test and other performance tests as secondary endpoints.
Biophytis says it hopes the drug candidate will enter phase 2 clinical trials in mid-2024, with first results potentially available as early as 2025.
The biotech is preparing to file an application to start the study in the USA in the coming weeks.
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