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A Phase 1 Study of GZC8072 Tablets Following a Single Dose in Healthy Study Participants and Multiple Doses in Obese/Overweight Study Participants

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Lead sponsor: Gan & Lee Pharmaceuticals. to Gan & Lee Pharmaceuticals. · Enrollment increased: 112 → 126 participants · Start date changed from estimate of Sep 4, 2026 to Sep 2, 2026 · 3 more Show 6 more changesShow less
    • Lead sponsor: Gan & Lee Pharmaceuticals. to Gan & Lee Pharmaceuticals.
    • Enrollment increased: 112 → 126 participants
    • Start date changed from estimate of Sep 4, 2026 to Sep 2, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 2 of 17 entries
    • Site details revised
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This trial is conducted in China. This study plans to include 2 parts, i.e., a single-dose study and a multiple-dose study: The single-dose study will be conducted in healthy adult participants to evaluate the safety, tolerability, and pharmacokinetic profile of single doses of GZC8072 Tablets; The multiple-dose study will be conducted in obese or overweight study participants to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of multiple doses of GZC8072 Tablets.
Trial Details
NCT Number NCT07784699
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Healthy Subjects;Overweight or Obesity
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov