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Tirzepatide

Mounjaro, Zepbound, LY3298176

Quick Stats
Studies 183
Trials 100
Not Yet Recruiting PHASE2 INTERVENTIONAL NCT06737042

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Primary Objective
TimeFrame: 36 weeks
Description: To demonstrate that GZR18 24 mg, 36 mg, and 48 mg is superior to placebo based on percentage change in body weight after 36 weeks of treatment

Trial Information

NCT ID

NCT06737042

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Gan and Lee Pharmaceuticals, USA

Last Updated

December 15, 2025