Danish pharmaceutical company Novo Nordisk A/S (CPH:NOVO-B) (NYSE:NVO) on Friday announced positive results from the REDEFINE 1 phase 3 trial of CagriSema, a fixed-dose combination of cagrilintide and semaglutide.
The trial included 3,417 randomised people with obesity or overweight with one or more comorbidities and a mean baseline body weight of 106.9 kg. It demonstrated superior weight loss with CagriSema compared to individual components or placebo.
Results showed that people treated with CagriSema achieved a superior weight loss of 22.7% after 68 weeks compared with a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone. In addition, 40.4% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks, compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo.
The treatment was generally safe and well-tolerated.
A second pivotal phase 3 trial, REDEFINE 2, is being conducted in adults with type 2 diabetes and either obesity or overweight, with results expected in the first half of 2025.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA