2003 Editorial and Rates

Although the SYMMETRY Phase IIb trial of the FGF21 analogue efruxifermin did not meet its primary endpoint at 36 weeks, extended 96-week data suggest potential benefits in fibrosis reduction and liver health in patients with compensated cirrhosis due to MASH, supporting continued evaluation in Phase III studies.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Detailed Phase IIIb STEP UP trial results presented at the 2025 ADA Scientific Sessions found that an investigational 7.2 mg dose of Wegovy (semaglutide) led to a mean weight loss of 21% in adults with obesity and no diabetes, showing the potential to expand dosing options in obesity management.

In a Phase II trial, Amgen’s investigational therapy MariTide (maridebart cafraglutide) delivered significant, sustained weight loss of up to 20% in adults with obesity, with or without type 2 diabetes, alongside notable improvements in glycemic control, supporting its advancement to Phase III studies as a potential once-monthly treatment option.

How human-centered AI that is focused on customer, user, and employee experience can drive real transformation in clinical trials and beyond by aligning intelligent technologies with the people who use them.