Long-term phentermine for weight and heart health (LEAP)
2/2, Data Coordinating Center for the Long-term Effectiveness of the Anti-obesity medication Phentermine: the LEAP Trial
['FUNDING_OTHER'] · WAKE FOREST UNIVERSITY HEALTH SCIENCES · NIH-11181246
This project tests whether taking phentermine long-term helps adults with obesity keep weight off and how it affects heart and blood vessel health.
Quick facts
| Phase | ['FUNDING_OTHER'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | WAKE FOREST UNIVERSITY HEALTH SCIENCES (nih funded) |
| Locations | 1 site (WINSTON-SALEM, UNITED STATES) |
| Trial ID | NIH-11181246 on ClinicalTrials.gov |
What this research studies
You would be part of a multi-center effort coordinated from Wake Forest to follow adults with obesity who receive phentermine alongside lifestyle care. The project uses a randomized, controlled approach at five sites to compare long-term phentermine use with usual care while tracking weight, blood pressure, heart rate, and other cardiovascular risk measures. Study staff will monitor for side effects and adverse events over extended follow-up and collect routine clinical and safety data. Results will show whether extended phentermine treatment is both effective for maintaining weight loss and safe for heart health.
Who could benefit from this research
Good fit: Adults aged 21 and older with obesity, including those with high blood pressure, diabetes, or existing atherosclerotic cardiovascular disease, represent the likely candidates for this work.
Not a fit: People with certain cardiac conditions, uncontrolled hypertension, pregnancy, or who cannot take stimulant medications may not be eligible or likely to benefit from long-term phentermine.
Why it matters
Potential benefit: If successful, this could support an affordable, long-term medication option to help people with obesity maintain weight loss and possibly reduce cardiovascular risk.
How similar studies have performed: Short-term phentermine use has been commonly prescribed and can produce initial weight loss, but there have been no high-quality randomized trials proving its long-term safety or sustained benefit.
Where this research is happening
WINSTON-SALEM, UNITED STATES
- WAKE FOREST UNIVERSITY HEALTH SCIENCES — WINSTON-SALEM, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: PAJEWSKI, NICHOLAS M. — WAKE FOREST UNIVERSITY HEALTH SCIENCES
- Study coordinator: PAJEWSKI, NICHOLAS M.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Atherosclerotic Cardiovascular Disease