Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss (GZR18-BWM-303)

March 10, 2026 updated by: Gan & Lee Pharmaceuticals.

A Multicenter Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss

This is a Phase 3 extension study conducted in subjects who have received GZR18 Injection once every 2 weeks (Q2W) for weight loss treatment for 52 weeks, aiming to explore the effect and safety of continuous injection of GZR18 Injection once every 4 weeks (Q4W) for 24 weeks on body weight.

In this study, it is planned to include subjects who have participated in the original study and completed the study contents of the original protocol. All subjects will maintain a regular diet and exercise lifestyle during the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

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 Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, Beijing
        • Not yet recruiting
        • Study site 01
        • Contact:
          • yue NA Liu
          • Phone Number: 010-56456739
      • Beijing, Beijing Municipality, China, Beijing
        • Recruiting
        • Study site 01
        • Contact:

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:

  1. Subjects who participated in the original study, completed the last dose at W50, EOT visit at W52 and safety follow-up visit at W55 of either original study, with last dose at W50 ≥ 24 mg (including blinded dose of placebo).
  2. Subjects with BMI > 18.5 kg/m² at W55 of the original study and before randomization at Visit 2 (V2) of this study, who are assessed by the investigator as suitable for participating in this study.
  3. 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 or ovum donation. Non-lactating women of childbearing potential (WOCBP) with a negative pregnancy test result before randomization at V2 in this study.

  4. Able to understand the procedures and methods of this study, willing and able to maintain a regular diet and exercise lifestyle during the study period, willing and able to undergo subcutaneous injections of the investigational medicinal product (IMP), and willing to sign the ICF voluntarily.

    -

Exclusion Criteria:

  1. Subjects who used Semaglutide (Wegovy®) in the original study.
  2. Subjects with a previous diagnosis of any type of diabetes mellitus (excluding gestational diabetes mellitus).
  3. Subjects with FPG ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the central laboratory test at W52 visit of the original study.
  4. Subjects who plan to participate in another clinical study of an investigational medicinal product or device, or receive drug or non-drug therapies that affect body weight (excluding diet and exercise control) before completing all scheduled assessments in this clinical study.

  5. Subjects with any other factors (including but not limited to previous compliance in the original study) that may affect the efficacy or safety evaluation of this study as judged by the investigator.

    -

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 injection Dose1
Drug: GZR18 injection
Used as specified in the protocol
Experimental: GZR18 injection Dose2
Drug: GZR18 injection
Used as specified in the protocol
Experimental: GZR18 injection Dose3
Drug: GZR18 injection
Used as specified in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change (%) from baseline in body weight
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in weight;
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline body mass index (BMI)；
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in waist circumference, hip circumference, and waist-hip ratio (waist circumference/hip circumference)；
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in hemoglobin A1c (HbA1c) ;
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in fasting plasma glucose (FPG);
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in blood pressure (SBP and DBP);
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in total cholesterol (TC);
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in low-density lipoprotein cholesterol (LDL-C);
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in high-density lipoprotein cholesterol (HDL-C);
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in triglyceride (TG);
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Changes from baseline in free fatty acids.
Time Frame: from Week 0 (W0) to Week 24 (W24)
from Week 0 (W0) to Week 24 (W24)
Treatment-Emergent Adverse Events (TEAEs);
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)
Treatment-Emergent Serious Adverse Events (TESAEs);
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)
Pulse rate;
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)
Lipase;
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)
Amylase;
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)
Calcitonin
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)
The scores of Patient Health Questionnaire-9
Time Frame: from Week 0 (W0) to Week 25 (W25)
the highest/worst score during the trial (the higher scores mean a worse outcome
from Week 0 (W0) to Week 25 (W25)
GZR18 anti-drug antibody (ADA) and neutralizing antibody (NAb);
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)
Cross reaction between GZR18 ADA and endogenous glucagon-like peptide-1 (GLP-1).
Time Frame: from Week 0 (W0) to Week 25 (W25)
from Week 0 (W0) to Week 25 (W25)

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)

January 22, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZR18-BWM-303

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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