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

Part of paid clinical trials in Bessemer, Alabama.

Sponsor
Gan and Lee Pharmaceuticals, USA
Study ID
NCT06737042
Phase
PHASE2
Status
Completed

Conditions

  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GZR18 — DRUG
    GLP-1
  • Tirzepatide — DRUG
    Active Comparator

Study Details

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).

Key Dates

First listed
Dec 17, 2024
Start date
Feb 24, 2025
Status verified
Jul 2026
Primary completion
Feb 27, 2026
Completion
Feb 27, 2026

Study Design

Enrollment
326 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 24 mg GZR18 group
    24 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)
  • Experimental: 36 mg GZR18 group
    36 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)
  • Experimental: 48 mg GZR18 group
    48 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)
  • Active Comparator: Tirzepatide group
    Tirzepatide group: 57 participants receiving 15 mg tirzepatide

Primary Outcome Measure

Primary Objective [ Time Frame: 36 weeks ]

Locations (20)

FacilityCityStateZIPSite coordinators
KUR Research - Trinity @ Bessemer, AL Site NetworkBessemerAlabama35022-
KUR Research - Trinity @ Centreville Site NetworkCentrevilleAlabama35042-
ERG - Woodland Int'l Research GroupLittle RockArkansas72211-
ERG - Woodland Research NorthwestRogersArkansas72758-
Ark Clinical Research Ark-Fountain ValleyFountain ValleyCalifornia92708-
Ark Clinical Research Ark-Long BeachLong BeachCalifornia90815-
Clinedge - Central Valley Research, LLCModestoCalifornia95350-
Populace Health, LLC - Catalina Research InstituteMontclairCalifornia91763-
East Coast Institute for Research - ECIR Jacksonville (Southside)JacksonvilleFlorida32216-
East Coast Institute for Research ECIR Jacksonville (Headquarters) UniversityJacksonvilleFlorida32216-
3Sync Research - PCRS NetworkLake WorthFlorida33460-
Clever Medical Research - PCRS NetworkMiamiFlorida33126-
KUR Research @ Columbia Site NetworkColumbiaMaryland21045-
Populace Health, LLC - Elixia SISUSpringfieldMassachusetts01103-
Populace Health, LLC - Vector Clinical TrialsLas VegasNevada89128-
Populace Health, LLC - CTI Clinical Research CenterCincinnatiOhio45212-
ERG - Ohio Clinical TrialsColumbusOhio43212-
Elligo Clinical Research Center - AustinAustinTexas78704-
Clinvax Katy Research CenterKatyTexas77493-
Endeavor Clinical TrialsSan AntonioTexas78229-

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