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Body weight reduction

Metabolicยท appears in 400+ cited findings in this library

What it is and how the reviews use it

Body weight reduction is an endpoint used in regulatory review documents to assess changes in a subject's body weight. It is frequently measured as a percentage change from baseline or as an absolute change in kilograms. This endpoint can serve as a primary or secondary outcome in clinical trials, particularly for drugs targeting metabolic conditions, obesity, or diabetes.

Regulatory reviews in this library frequently report body weight reduction. For instance, the RHYTHM โ€” Imcivree FDA Review noted an "Average weight loss" of 9.7%. The JANSSEN PHARMS โ€” Invokana FDA Review reported a "Body Weight % change from baseline" of -3.9%. The Boehringer Ingelheim โ€” Jardiance FDA Review highlighted a "Difference in Body Weight from glimepiride (adjusted mean)" of -5.9%.

Real examples โ€” cited to the source page

ImcivreeAverage weight loss9.7 %RHYTHM โ€” Imcivree FDA Review, p.11
InvokanaBody Weight % change from baseline-3.9 %JANSSEN PHARMS โ€” Invokana FDA Review, p.36
JardianceDifference in Body Weight from glimepiride (adjusted mean)-5.9 %Boehringer Ingelheim โ€” Jardiance FDA Review, p.29
JentaduetoBody weight change from baseline vs placebo1.46 kgBoehringer Ingelheim โ€” Jentadueto EMA EPAR variation assessment report, p.28
ZepboundAHI improvement from baseline with body weight reduction50 %ELI LILLY AND CO โ€” Zepbound (Autoinjector) FDA Review, p.212
MounjaroBody weight reduction (comparator-subtracted) for tirzepatide 10 mg-3.6 to -11.5 kgEli Lilly and Company โ€” Mounjaro FDA Review, p.19
RybelsusBody Weight Change from Baseline-4.36 kilogramsNOVO โ€” Rybelsus FDA Review, p.23
SaxendaMean weight loss7.5 %Novo Nordisk A S โ€” Saxenda EMA EPAR public assessment report, p.63

Different drugs were studied in different trials โ€” these values are not head-to-head comparisons.

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Figures are as stated in the cited source documents. Educational reference only โ€” not medical or investment advice.

Body weight reduction โ€” Explained with Cited FDA & EMA Examples | BioPharmaPT Metabolic