Generalizability of clinical trials of novel weight loss medications to the US adult population

JAMA Internal Medicine

About The Study: 

This study estimates that approximately one-third of U.S. adults without diabetes who were eligible for weight loss treatment with glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) were excluded from clinical trials supporting these medications’ safety and effectiveness. Until there is evidence from high-quality postmarketing studies, the FDA should consider updating labeling to advise caution on generalizing the safety and effectiveness of GLP-1 and GLP-1/GIP to populations excluded from pivotal trials.

Corresponding Author: To contact the corresponding author, Timothy S. Anderson, MD, MAS, email tsander@pitt.edu.

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(doi:10.1001/jamainternmed.2024.6340)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

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Journal

JAMA Internal Medicine