Novo Nordisk said Sunday that two analyses of its experimental obesity drug CagriSema examined weight-loss patterns and daily functioning as the company awaits a U.S. regulatory decision.
In the response analysis, 1,367 of 2,016 participants, or 67.8%, had lost at least 5% of their weight by week eight. The other 649 participants had not reached that threshold by then.
At week 68, the early responders averaged 25.4% weight loss, compared with 17.8% for those who had not reached the threshold. These figures reflect observed results among participants still taking treatment. Novo described the post hoc analysis as hypothesis-generating.
EconoTimes previously covered the early-response analysis.
REDEFINE 1 randomized 3,417 adults with obesity or overweight across four treatment groups. About two-thirds of participants were women. In a broader treatment-policy analysis of the trial, the CagriSema group recorded an average 20.4% weight loss, compared with 3% for placebo.
A separate analysis of women in REDEFINE 1 estimated average weight loss of 25% over 68 weeks, assuming participants stayed on treatment. That women-only analysis and the whole-trial result used different populations and methods from the new response-group analysis.
Novo said a separate post hoc analysis found that 73.1% of adults taking CagriSema reported a meaningful improvement in physical function at week 68, compared with 49.1% taking placebo; the analysis used an efficacy estimand that assumes participants adhered to treatment.
CagriSema combines semaglutide, used in Wegovy and Ozempic, with cagrilintide, which affects biological signaling tied to hunger and fullness. Novo expects the U.S. Food and Drug Administration to decide on the treatment for weight management in the fourth quarter of 2026.
