Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects

Sponsor
Gan & Lee Pharmaceuticals.
Study ID
NCT07150975
Phase
PHASE3
Status
Recruiting
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Conditions

  • Obesity/Overweight in Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate the efficacy and safety of GZR18 Injection in this population.

Key Dates

Start date
Sep 23, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GZR18 Dose Level 1
  • Experimental: GZR18 Dose Level 2
  • Active Comparator: Semaglutide(Wegovy® )2.4 mg

Primary Outcome Measure

Percentage change in body weight from baseline after 52 weeks (W) of treatment. [ Time Frame: From Week 0 to Week 52 ]

Central Contacts