REFERENCE BRIEF No 09

the cagrisema titration schedule from the REDEFINE phase 3 trial

published

the 20-week ladder used in REDEFINE phase 3, pre-approval.

3 MIN READ · 594 WORDS · 2026-05-14

cagrisema · titration · dosing · REDEFINE · GLP-1 · cagrilintide · semaglutide

As of October 24, 2026, CagriSema is not FDA-approved: FDA's Drugs@FDA data list no application containing cagrilintide, the ingredient it adds to semaglutide.

REDEFINE 1 (NCT05567796) is Novo Nordisk's phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg with semaglutide 2.4 mg, against each drug alone and placebo, in adults with obesity, or overweight and a weight-related condition, without diabetes. ClinicalTrials.gov lists an estimated 3,400 participants and the relative change in body weight from baseline to week 68 as a primary outcome.

In the published results, mean body weight fell 20.4% with the combination against 3.0% with placebo over 68 weeks (treatment-policy estimand).

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