Novo Nordisk Reveals 68-Week Weight Loss Results from REDEFINE 1 Trial

Novo Nordisk has recently revealed promising data from its Phase III clinical trial, REDEFINE 1, concerning the use of a combination therapy of semaglutide and Cagrilintide in aiding weight loss. This extensive study involved 3,417 participants who were either obese or overweight, each possessing at least one health risk associated with their weight.

The trial's findings, after 68 weeks of treatment, show significant results in terms of dosage and weight reduction. In the CagriSema treatment group, 57.3% of the participants reached the highest dose level. This is compared to 82.5% in the Cagrilintide group and 70.2% in the semaglutide group. As for the placebo group, weight loss was modest.

In terms of effectiveness, the weight reduction percentages were noteworthy. Those receiving the CagriSema combination therapy exhibited a 22.7% decrease in body weight. Meanwhile, the Cagrilintide group saw an 11.8% reduction, the semaglutide group achieved a 16.1% decrease, and the placebo group only managed a 2.3% reduction. When compared with the placebo group, CagriSema led to a 20.4% greater weight loss, with Cagrilintide and semaglutide showing 9.5% and 13.8% more weight loss, respectively.

CagriSema is currently being tested in five ongoing Phase III clinical trials. One of these, known as REDEFINE 4, aims to directly compare its efficacy with that of tirzepatide. Novo Nordisk is hopeful that this combination therapy will match the weight loss effectiveness of tirzepatide.

Historically, the CagriSema combination has demonstrated encouraging weight loss outcomes in earlier trials. In Phase I trials, it resulted in a 17% reduction in body weight over a 20-week period. Similarly, in Phase II trials targeting patients with diabetes and excess weight, participants saw a 15.6% reduction over 32 weeks. Novo Nordisk had previously set a target for the Phase III trials, aiming for at least a 25% weight loss outcome.

In another development, Betta Pharmaceuticals has achieved a significant milestone with its ALK inhibitor, ensartinib, now approved by the U.S. Food and Drug Administration (FDA). It will be marketed as Ensacove for treating ALK-positive locally advanced or metastatic non-small cell lung cancer.

This approval follows the results from the eXALT3 clinical trial, which compared ensartinib directly with the existing treatment, crizotinib. The main focus was on progression-free survival (PFS), with overall survival (OS) as a vital secondary endpoint. Ensartinib showed a median progression-free survival of 25.8 months, significantly outperforming crizotinib, which had a median of 12.7 months. This reflects a 44% reduction in the risk of disease progression or death. However, no significant difference was observed in the overall survival rates between the two treatments, marked by a hazard ratio of 0.88.

Regarding safety, the most prevalent side effects reported were skin rash, musculoskeletal pain, constipation, cough, itching, nausea, edema, fever, and fatigue. These findings underscore the potential of ensartinib as a viable option for patients with advanced non-small cell lung cancer.