Published On: 2/2/2021

Target RWE Shares Weight Loss Data From Ongoing NASH Study

Real-world study shows only 32% of overweight or obese adults with NAFLD in the U.S. achieved 5% or more weight reduction

DURHAM, N.C., Feb. 2, 2021 /PRNewswire/ -- Target RWE, a leading real-world evidence (RWE) solutions company for the pharmaceutical and biotech industries, shared the latest data from the ongoing TARGET-NASH observational study, published in Clinical Gastroenterology & Hepatology (https://doi.org/10.1016/j.cgh.2021.01.023).

The nonalcoholic steatohepatitis (NASH) study, Weight Loss and Weight Regain in Usual Clinical Practice: Results from the TARGET-NASH Observational Cohort, analyzed 2,019 patients enrolled in the TARGET-NASH cohort in the United States over a median follow-up of 39 months. The baseline characteristics included one third of patients classified as obesity class 2/3, 38.6% of patients had diabetes, and approximately 50% had documentation of lifestyle modifications or diet recommendations.

Over a median follow-up of 39 months, the study found the following results:

• 32% of patients had weight reduction of 5% or more;
• Median time to initial weight loss was shorter in patients who were obesity class 2/3; and
• Only 25% of patients maintained 5% or more weight loss.

"We know that obesity and metabolic syndrome are major risk factors for the development of nonalcoholic fatty liver disease (NAFLD), and its more severe form, NASH. Thus, lifestyle modifications such as weight reduction are a critical step in the treatment of the disease," said Miguel Malespin, MD, Transplant Hepatology Specialist, Tampa General Hospital, and lead author on the manuscript. "The results of weight loss and weight gain from the TARGET-NASH cohort can help inform future studies of management of NAFLD."

"Our analyses found that among those with initial weight loss, 21% regained weight back to baseline during follow-up, and 59% of those patients did so within the first year of weight loss," said Anna Lok, MD, Professor of Medicine, University of Michigan, and senior author. "These data have implications for identifying patient populations who are more or less likely to lose weight in the absence of pharmacological interventions and provide important background information for the interpretation of clinical trial results."

TARGET-NASH is a longitudinal study of adults and pediatric participants with NAFLD and/or NASH in usual clinical practice. Target RWE's NASH sites include 65 community and academic centers in the U.S. and Europe that have enrolled more than 5,700 participants to date. Three years of retrospective data is obtained at time of enrollment and patients are then followed prospectively for a minimum of 5 years, including patient-reported outcome measures and biospecimen samples.