NCT06737042

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

EFFICACY and SAFETY of GZR18 INJECTED EVERY 2 WEEKS (Q2W) in PARTICIPANTS WITHOUT TYPE 2 DIABETES, WHO HAVE OBESITY or ARE OVERWEIGHT: a RANDOMIZED, TIRZEPATIDE- and PLACEBO-CONTROLLED STUDY

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 2 multicenter, randomized, parallel-group, partially-blinded, placebo and tirzepatide-controlled study of 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). The study will comprise a 2-week screening period (Days -14 to -1), a 36-week treatment period (Weeks 0 to 36), which includes a titration period and a maintenance dose period, and a safety follow-up period of 2 weeks after the primary endpoint assessment (ie, 4 weeks after the last GZR18 dose and 3 weeks after the last tirzepatide dose). Approximately 285 participants will be randomized at Week 0 into 1 of 4 groups, stratified by sex. The study will be partially-blinded (intragroup blinded); treatment in the GZR18 groups will be blinded (GZR18 vs placebo), but GZR18 vs tirzepatide will be unblinded.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
DRUG	GZR18	GLP-1
DRUG	Tirzepatide	Active Comparator

Timeline

• Start date: 2025-02-12
• Primary completion: 2026-02-09
• Completion: 2026-06-22
• First posted: 2024-12-17
• Last updated: 2025-02-04

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study