The FDA accepted non-invasive Liver Stiffness Measurement as a surrogate endpoint for MASH clinical trials, replacing biopsies. This key decision accelerates MASH drug development by enabling safer monitoring, speeding recruitment, and predicting patient outcomes.
Eli Lilly's orforglipron showed positive results in its second Phase 3 obesity trial, achieving a weight loss of 9.6% at the highest dose. With a consistent safety profile, global regulatory submissions are imminent, aiming for 2026 approval.
Viking Therapeutics' oral VK2735 achieved up to 12.2% weight loss in a Phase 2 trial, which was below expectations. It is safe, well-tolerated, and has mild gastrointestinal effects.
Lilly's new oral GLP-1, orforglipron, shows 11-12.4% weight loss in late-stage trial, short of Zepbound and Wegovy. Easier to produce and distribute than injectables, it targets wider patient access. FDA submission this year.
