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
Not Yet Recruiting

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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

Start date
Feb 12, 2025
Status verified
Dec 2024
Primary completion
Feb 9, 2026
Completion
Jun 22, 2026

Study Design

Enrollment
285 participants (estimated)
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 ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
KUR Research - Trinity @ Bessemer, AL Site NetworkBessemerAlabama35022
Cindy Thome
205-225-7455
KUR Research - Trinity @ Centreville Site NetworkCentrevilleAlabama35042
Brianna White
205-225-7455
ERG - Woodland Int'l Research GroupLittle RockArkansas72211
Katheryn Willis
501-221-8681
ERG - Woodland Research NorthwestRogersArkansas72758
Tyler Karnes
479-316-0834
Ark Clinical Research Ark-Fountain ValleyFountain ValleyCalifornia92708
Norma Vega
714-988-2021
Ark Clinical Research Ark-Long BeachLong BeachCalifornia90815
Vanessa Delgado
562-997-1000
Clinedge - Central Valley Research, LLCModestoCalifornia95350
Haroon Hafeez, MBBS, MD
209-549-9538
Populace Health, LLC - Catalina Research InstituteMontclairCalifornia91763
Anne Arriaga
909-590-6324
East Coast Institute for Research - ECIR Jacksonville (Southside)JacksonvilleFlorida32216
Stephanie Niman
904-854-1354
East Coast Institute for Research ECIR Jacksonville (Headquarters) UniversityJacksonvilleFlorida32216
Katie Graf
904-854-1354
3Sync Research - PCRS NetworkLake WorthFlorida33460
Brad Schultz
800-733-7692
Clever Medical Research - PCRS NetworkMiamiFlorida33126
Margarita Hernandez
305-648-6381
KUR Research @ Columbia Site NetworkColumbiaMaryland21045
Brittney Lewis Weekes
443-362-1957
Populace Health, LLC - Elixia SISUSpringfieldMassachusetts01103
Brittany Perreault
413-305-1144
Populace Health, LLC - Vector Clinical TrialsLas VegasNevada89128
Shonda Lunceford
702-750-0000
Populace Health, LLC - CTI Clinical Research CenterCincinnatiOhio45212
Kendra Lewis
513-841-5304
ERG - Ohio Clinical TrialsColumbusOhio43212
Angela Eakin, MD
614-754-7679
Najib Tabal, MBBCh
614-298-8086
Elligo Clinical Research Center - AustinAustinTexas78704
Michael Giammona
512-989-5959
Clinvax Katy Research CenterKatyTexas77493
Amy Ade
832-600-0822
Endeavor Clinical TrialsSan AntonioTexas78229
Brian Purcell
210-634-1253

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