Weight Loss and Weight Regain in Usual Clinical Practice: Results from the TARGET-NASH Observational Cohort

Weight loss is a primary treatment goal in NAFLD, but real-world data on whether patients achieve and sustain clinically meaningful weight loss in usual care—and the predictors of weight regain—were lacking, leaving a gap between clinical trial benchmarks and realistic treatment expectations.

The TARGET-NASH observational cohort was used to track weight loss and regain trajectories over time in patients receiving standard care, characterizing the real-world effectiveness of lifestyle intervention and providing empirical benchmarks for trial comparator arms.

Documenting that weight regain is common in real-world NAFLD care sets realistic expectations for comparator arm behavior in trials, supports the design of weight-loss-sensitive endpoints, and demonstrates the unmet need for pharmacological intervention beyond lifestyle modification.

Real-world weight loss trajectory benchmarking for trial design, Comparator arm behavior characterization for MASLD clinical trials, Lifestyle intervention effectiveness data for drug development context