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GZR18-BWM-303

RecruitingPhase 3

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

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

Lead sponsor

Gan & Lee Pharmaceuticals.

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

500

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥18.5

Primary endpoint

•Percent change (%) from baseline in body weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07292441

Org study IDGZR18-BWM-303

Timeline

Milestones

Study first posted2025-12-18actual

Study start2026-01-22actual

Last update posted2026-03-11actual

Primary completion2027-09estimated (month precision)

Study completion2027-10estimated (month precision)

Assets

Investigational agents

GZR18

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

Patient-reported / QoL