Novo Nordisk Announces 68-Week Weight Loss Data from REDEFINE 1 Clinical Trial

Recently, Novo Nordisk announced the efficacy and safety data from its semaglutide and Cagrilintide combination therapy in the weight loss domain from the Phase III clinical trial REDEFINE 1. This clinical trial recruited 3,417 obese or overweight patients, each with at least one weight-related risk factor.

After 68 weeks of treatment, 57.3% of patients in the CagriSema treatment group reached the highest dose. In comparison, 82.5% and 70.2% of patients in the Cagrilintide and semaglutide monotherapy groups reached the highest dose, respectively. Regarding weight loss efficacy, the weight loss percentages after 68 weeks of treatment were 22.7%, 11.8%, 16.1%, and 2.3% for CagriSema, Cagrilintide, semaglutide, and the placebo group, respectively. Compared to the placebo, the weight loss amounts during the 68 weeks were 20.4%, 9.5%, and 13.8% for CagriSema, Cagrilintide, and semaglutide, respectively.

Currently, CagriSema is undergoing five Phase III clinical trials, one of which, REDEFINE 4, will directly compare it with tirzepatide. Novo Nordisk hopes that CagriSema can achieve weight loss effects comparable to tirzepatide.

Previously, CagriSema achieved a 17% weight loss effect over 20 weeks in Phase I trials and a 15.6% weight loss effect over 32 weeks in Phase II trials targeting patients with diabetes and overweight. Novo Nordisk previously anticipated that the Phase III clinical trials could achieve a weight loss of at least 25%.

Additionally, Betta Pharmaceuticals' ALK inhibitor ensartinib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer, marketed under the name Ensacove.

This approval is based on the data from the eXALT3 clinical trial, which directly compared ensartinib with crizotinib. The primary endpoint was progression-free survival (PFS), and the key secondary endpoint was overall survival (OS). The median progression-free survival (mPFS) for ensartinib and crizotinib was 25.8 months and 12.7 months, respectively, reducing the risk of disease progression or death by 44%. There was no significant difference in overall survival between the two groups, with a hazard ratio (HR) of 0.88. In terms of safety, the most common side effects included rash, musculoskeletal pain, constipation, cough, itching, nausea, edema, fever, and fatigue.