Biophytis SA expanded its obesity study to examine whether BIO101 can limit weight regain after semaglutide treatment, within an agreement under which it could receive up to €108 million. The change matters because the program now covers muscle-function support during weight loss and follow-up after treatment ends, with study start targeted for 2027.

Key Highlights

  • Biophytis submitted the amended obesity-study protocol to Brazil’s ANVISA on September 9, 2026.
  • The company expects to submit the amendment to the FDA in the coming days and to the EMA in the coming weeks.
  • Biophytis expects the OBA study to begin with its first patient in 2027 and report results in the first half of 2028.

Protocol Adds Post-Treatment Weight-Regain Assessment

The amended protocol broadens the study beyond muscle function and mobility during weight loss. Biophytis submitted the amended protocol to Brazil’s Health Regulatory Agency, ANVISA, on September 9, 2026. The revised plan adds an evaluation period after semaglutide discontinuation to examine weight regain and BIO101’s potential role in maintaining treatment benefits. The existing study evaluates BIO101 alongside a GLP-1 receptor agonist in obese or overweight patients, focusing on lower-limb muscle strength and mobility.

OBA Program Moves Toward 2027 Start

The company’s stated objective is to explore whether BIO101 can help preserve muscle mass, strength and mobility while also limiting weight regain. The first patient visit is expected in 2027, with results targeted for the first half of 2028.