Application of the Lancet Commission Criteria for the Diagnosis of Obesity to a Clinical Trials Population: The LEAP Trial
Authors' conclusion
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.
Study context
- Population
- Participants of the LEAP phentermine trial, eligible for obesity pharmacotherapy
- Participants
- 860 participants
- Exposure
- No obesity vs pre-clinical obesity vs clinical obesity
- Outcome
- Obesity status by Lancet criteria
- Follow-up
- Baseline
Methodological detailsbaseline data of the LEAP trial
- Baseline data of the LEAP trial
Main finding
As reported in the abstract
| Group | Value | Mean BMI |
|---|---|---|
| No obesity | 0.8% | 29.0 kg/m² (SD 0.6) |
| Pre-clinical obesity | 18.7% | 35.2 kg/m² (SD 3.5) |
| Clinical obesity | 80.5% | 35.9 kg/m² (SD 4.3) |
Value
No obesity0.8%
Pre-clinical obesity18.7%
Clinical obesity80.5%
Mean BMI
No obesity29.0 kg/m² (SD 0.6)
Pre-clinical obesity35.2 kg/m² (SD 3.5)
Clinical obesity35.9 kg/m² (SD 4.3)
Observational data: associations, not effects.
Further findings
Characteristics by obesity status · baseline
- No/pre-clinical obesity had lower mean SF-12 mental component scores and greater engagement with weight control strategies vs clinical obesity
- Clinical obesity were older and, by definition, had greater burden of cardiometabolic risk factors
Original publication
Application of the Lancet Commission Criteria for the Diagnosis of Obesity to a Clinical Trials Population: The LEAP Trial. Obesity (Silver Spring). Published 27 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →