Significant Portion of Eligible Adults for Weight Loss Medications Do Not Meet Clinical Trial Criteria

Recent research indicates that approximately one-third of U.S. adults who qualify for weight loss treatments involving glucagon-like peptide-1 (GLP-1) receptor agonists and GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists do not satisfy the exclusion criteria for clinical trials. This finding was detailed in a research publication in JAMA Internal Medicine.

The study, conducted by researchers at the University of Pittsburgh, examined the eligibility of individuals for GLP-1 and GLP-1/GIP treatments based on U.S. Food and Drug Administration (FDA) label criteria. The researchers utilized pooled data from the National Health and Nutrition Examination Survey to assess the overlap between the FDA eligibility standards and the exclusion criteria observed in clinical trials.

In their analysis, the researchers evaluated a cohort of 8,767 participants, a sample that represents approximately 110.3 million U.S. adults with overweight or obesity. The study revealed that a significant percentage of participants met the FDA criteria for weight loss medications: 88.9% for liraglutide, 89.0% for semaglutide, and 90.6% for tirzepatide. However, among those deemed eligible for treatment, notably high percentages also met the exclusion criteria: 28.1% for liraglutide, 26.2% for semaglutide, and 33.1% for tirzepatide.

Furthermore, the analysis indicated that older adults, particularly those aged 60 and above, were more likely to meet at least one exclusion criterion compared to younger demographics. The most prevalent exclusion criteria included major depressive disorder, malignant neoplasms, liver disease (specifically for tirzepatide), and uncontrolled hypertension.

The findings of this research raise important considerations regarding the generalizability of clinical trial results to the broader population. Given that a substantial portion of eligible individuals do not align with the stringent criteria set forth in clinical trials, the authors advocate for the FDA to revise labeling practices. They suggest that the FDA should emphasize caution when applying the findings of pivotal trials to populations that were excluded from these studies.

This research underscores the need for further investigations, particularly high-quality post-marketing studies, to better understand the safety and effectiveness of GLP-1 and GLP-1/GIP medications in diverse patient populations that may not have been adequately represented in clinical trials.

In summary, while a significant number of U.S. adults qualify for GLP-1 and GIP weight loss drugs according to FDA guidelines, many do not meet the criteria for participation in clinical trials. This discrepancy highlights the complexities of translating clinical trial outcomes to wider patient populations and emphasizes the importance of ongoing research in this area.