Signal Cards

Treatment-regimen weight changes: -7.5%, -8.4% and -11.2% across the three doses versus -2.1% placebo.

Sponsor efficacy-estimand weight loss: 23.0% vs 25.5%; treatment-regimen estimates: 20.2% vs 23.6%. CagriSema did not demonstrate noninferiority.

Treatment-policy weight loss in the obesity cohort ranged from 12.3% to 16.2%, versus 2.5% with placebo.

Sponsor reported up to 14.6% mean weight loss in the 40 mg group, versus 2.1% placebo.

Treatment-regimen mean weight changes: -12.2% and -13.0%, versus -5.4% placebo.

Pooled changes: body weight -21.3%, fat mass -33.9%, lean mass -10.9%. Approximately 75% of lost weight was fat and 25% lean tissue.

Reported changes included fat mass -19.3% and lean mass -9.7% with semaglutide.

At week 48, mean weight change was -24.2% in the 12 mg group versus -2.1% with placebo.

The evidence supports reduction of excess abdominal fat in the indicated population.

No adverse effects were reported in the two participants during the observation period.

At week 48, the high-dose combination produced -17.8 kg weight change versus -14.2 kg with semaglutide 2.4 mg (treatment-regimen estimand). Combinations reduced lean-mass loss relative to semaglutide alone.

Sponsor reported reduced lean-mass loss with combinations versus semaglutide alone.

This is a registered regimen, not a result. The separate QUALITY findings summarized above are sponsor-reported.

Weight, fat and lean-mass outcomes are planned; no posted results in the reviewed record.

Insulin sensitivity is being studied; no results are posted.

Between-group difference: 1.9 kg less lean-mass loss (80% CI 1.2–2.7), with similar weight loss.

Efficacy-estimand weight reduction was approximately 20% in the 9 mg group versus 0.4% placebo.