Application of the Lancet Commission Criteria for the Diagnosis of Obesity to a Clinical Trials Population: The LEAP Trial

Authors

• Faith Anne N Heeren
• Kathleen R Ruddiman
• Courtney Simmons
• Brian N White
• Byron C Jaeger
• Nicholas M Pajewski
• Stephanie A Hooker
• Deborah B Horn
• Katy Martin-Fernandez
• Kimberly A Gudzune
• Caroline Blackwell Young
• Jamy Ard
• Kristina Henderson Lewis

Language

English

Publication Date

1-1-2026

Journal

Obesity

DOI

10.1002/oby.70070

PMID

41145317

PMCID

PMC12724050

PubMedCentral® Posted Date

10-27-2025

PubMedCentral® Full Text Version

Post-print

Abstract

Objective: This study aimed to apply The Lancet Diabetes & Endocrinology criteria for diagnosing obesity among clinical trial participants and understand participants' characteristics by obesity status.

Methods: The criteria were operationalized and applied to baseline data from the Long-term Effectiveness of the Anti-obesity medication Phentermine (LEAP) trial (NCT05176626). Excess adiposity, organ and tissue dysfunction, and limitations to daily activities were assessed. We examined differences between participants with "no obesity," "pre-clinical obesity," and "clinical obesity."

Results: Among the 860 participants, 0.8% had no obesity (mean BMI 29.0 kg/m2 [SD 0.6]), 18.7% had pre-clinical obesity (mean BMI 35.2 kg/m2 [SD 3.5]), and 80.5% had clinical obesity (mean BMI 35.9 kg/m2 [SD 4.3]). Participants with no/pre-clinical obesity had lower mean SF-12 mental component scores and greater baseline engagement with weight control strategies compared to those with clinical obesity. Participants with clinical obesity were older and, by definition, had a greater burden of cardiometabolic risk factors.

Conclusions: Among clinical trial participants eligible for obesity pharmacotherapy, 19.5% were classified as having no/pre-clinical obesity using the Lancet criteria. Applying the criteria was complicated in a well-resourced trial setting, which suggests potential challenges in implementing these guidelines in real-world practice.

Keywords

Adult, Aged, Female, Humans, Male, Middle Aged, Adiposity, Anti-Obesity Agents, Body Mass Index, Obesity, Phentermine

Published Open-Access

yes

Recommended Citation

Heeren, Faith Anne N; Ruddiman, Kathleen R; Simmons, Courtney; et al., "Application of the Lancet Commission Criteria for the Diagnosis of Obesity to a Clinical Trials Population: The LEAP Trial" (2026). Faculty, Staff and Student Publications. 4515.
https://digitalcommons.library.tmc.edu/uthmed_docs/4515