drugset / Trial / NCT06737042

Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants

NCT06737042 ↗

Phase 2 Completed 326 enrolled Gan and Lee Pharmaceuticals, USA
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).

Timeline

Start
2025-02-24
Primary completion
2026-02-27
Completion
2026-02-27

Outcome

Met primary endpoint

release “bofanglutide Injection in adults with overweight/obesity in the United States also met its primary endpoint” ganlee.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bofanglutide Protein / enzyme biologic 24 mg —
Subject Bofanglutide Protein / enzyme biologic 36 mg —
Subject Bofanglutide Protein / enzyme biologic 48 mg —
Comparator Tirzepatide Peptide 15 mg —

Indications