Clinical Trial

Long-term Effectiveness of the Antiobesity Medication Phentermine

Study acronym: LEAP
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The purpose of this research study is to understand the long-term effects of the drug phentermine on weight, blood pressure, other health outcomes, and safety. Phentermine has been approved by the US Food and Drug Administration (FDA) for weight management since 1959, but it has not been approved for long-term use (i.e., treatment lasting more than 12 weeks). This trial is designed to learn about the long-term effects of phentermine for up to 2 years because obesity is a chronic disease and expert guidelines recommend long-term use of anti-obesity medications as one treatment option.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-12-15; most recent amendment 2026-03-25.
Status change: Recruiting → Active, Not Recruiting 2024-10-16
Status change: Not Yet Recruiting → Recruiting 2022-06-23
Trial Details
NCT Number NCT05176626
Lead Sponsor Wake Forest University Health Sciences
Collaborators: Johns Hopkins University, Kaiser Permanente, HealthPartners Institute, The University of Texas Health Science Center, Houston, Biomedical Research Institute of New Mexico, WW International Inc, KVK-Tech, Inc., National Heart, Lung, and Blood Institute (NHLBI)
Conditions Obesity, Obesity; Drug, Lifestyle, Healthy
Enrollment 870 participants
Start Date 2022-06-30
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-31