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Long-term Effectiveness of the Antiobesity Medication Phentermine

Study acronym: LEAP
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Publications: 2 to 3v11
  2. Re-verified, no change to tracked fieldsv10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1000 to confirmed 870
    • Site details revised at 4 of 4 sites
    v9
  4. Primary and study completion dates: Dec 2026 to Dec 31, 2026v8
  5. Primary and study completion dates: Sep 2025 to Dec 2026
    • Secondary endpoints: details revised at 1 of 4 entries
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 3 of 4 sitesv6
  2. Study sites: 5 to 4
    • Eligibility criteria expanded, about 24 words
    v5
  3. Site details revised at 3 of 5 sitesv4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2022 to Jun 30, 2022
    • Site details revised at 5 of 5 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Obesity, Obesity; Drug, Lifestyle, Healthy
Related terms Obesity, Weight Loss
Enrollment 870 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov