Trial
BELIEVE
Research Observatory
Evidence Update
Current evidence
BELIEVE tested bimagrumab and semaglutide, separately and in combination, against placebo across nine randomized groups in 507 adults with obesity or overweight plus a complication, without diabetes. The higher-dose bimagrumab–semaglutide combination had a larger nominal week-48 weight reduction than the component groups. These treatment-regimen comparisons were not adjusted for multiplicity; the week-72 open-label extension is a separate analysis, not a continued true-placebo comparison.
What changed
Adds the treatment-regimen estimate of -17.8 kg for the high-dose combination versus -3.3 kg placebo.
What did not change
Week-72 extension data are not another independent trial or continued true-placebo comparison.
Why it matters
The trial's estimand and phase determine which number is appropriate.
Main limitation
Semaglutide was open-label and tests lacked multiplicity adjustment. Extension and post-hoc findings are exploratory; DXA lean mass does not establish strength or physical function.
Next proof
Confirmatory function, safety and withdrawal-durability data.
Summary
BELIEVE tested nine randomized groups in 507 adults without diabetes; the high-dose combination had a larger nominal week-48 weight reduction than component groups.
Intelligence Take
The trial's estimand and phase determine which number is appropriate.
Limitations
Semaglutide was open-label and tests lacked multiplicity adjustment. Extension and post-hoc findings are exploratory; DXA lean mass does not establish strength or physical function.