A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

November 20, 2025 updated by: Gan & Lee Pharmaceuticals.

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

630

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.
  • Obese (BMI ≥ 28 kg/m2) or overweight (24 kg/m2 ≤ BMI < 28 kg/m2) with at least one comorbidity.
  • Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
  • Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).

Exclusion Criteria:

  • Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.
  • History of drug abuse prior to screening.
  • History of alcohol abuse within 6 months before screening.
  • Weight change of > 5.0% within 3 months before screening (self-report).
  • Presence of limb deformity or mutilation affecting height measurement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Administered the same volume as GZR18
Experimental: GZR18
Drug: GZR18
Used as specified in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in weight from baseline (%)
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48
Changes from baseline in weight
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48
Changes from baseline in body mass index (BMI)
Time Frame: From Week 0 to Week 48
weight and height will be combined to report BMI in kg/m^2
From Week 0 to Week 48
Changes from baseline in hip circumference
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48
Changes from baseline in waist circumference
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48
Changes from baseline in waist-hip ratio (waist circumference/hip circumference)
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48
Treatment emergent adverse events (TEAEs)
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gan & Lee Pharmaceuticals.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZR18-BWM-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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