drugset / Trial / NCT05176626
Long-term Effectiveness of the Antiobesity Medication Phentermine
Phase 4
Active not recruiting
870 enrolled
Wake Forest University Health Sciences
Biomedical Research Institute of New Mexico · collabHealthPartners Institute · collabJohns Hopkins University · collabKVK-Tech, Inc. · collabKaiser Permanente · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabThe University of Texas Health Science Center, Houston · collabWW International Inc · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-06-30
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Publications
- Background Young CB, Rives E, Gudzune KA, Jaeger BC, Simmons CG, White BN, Hooker SA, Horn DB, Young DR, Vesely J, Velazquez A, Price C, Cook SD, Martin-Fernandez K, Inzhakova G, Pajewski NM, Ard JD, Lewis KH. The long-term effectiveness of the anti-obesity medication phentermine (LEAP) trial: Rationale, design, and baseline characteristics. Contemp Clin Trials. 2026 Feb;161:108219. doi: 10.1016/j.cct.2026.108219. Epub 2026 Jan 8.
- Background Ziegenfuss JY, Sour EU, Roelofs EJ, Vesely JM, Margolis KL, Hooker SA. A randomized study comparing patient portal and email communications for trial recruitment. Clin Trials. 2025 Oct;22(5):597-606. doi: 10.1177/17407745251358259. Epub 2025 Aug 21.
- Background Heeren FAN, Ruddiman KR, Simmons C, White BN, Jaeger BC, Pajewski NM, Hooker SA, Horn DB, Martin-Fernandez K, Gudzune KA, Young CB, Ard J, Lewis KH. Application of the Lancet Commission Criteria for the Diagnosis of Obesity to a Clinical Trials Population: The LEAP Trial. Obesity (Silver Spring). 2026 Jan;34(1):58-64. doi: 10.1002/oby.70070. Epub 2025 Oct 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Phentermine | Small molecule | 24 mg | Oral |