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

NCT ID: NCT07292441

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered the same volume as GZR18

GZR18 injection Dose1

Group Type EXPERIMENTAL

GZR18 injection

Intervention Type DRUG

Used as specified in the protocol

GZR18 injection Dose2

Group Type EXPERIMENTAL

GZR18 injection

Intervention Type DRUG

Used as specified in the protocol

GZR18 injection Dose3

Group Type EXPERIMENTAL

GZR18 injection

Intervention Type DRUG

Used as specified in the protocol

Interventions

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GZR18 injection

Used as specified in the protocol

Intervention Type DRUG

Placebo

Administered the same volume as GZR18

Intervention Type OTHER

Eligibility Criteria

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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.

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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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gan & Lee Pharmaceuticals.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Study site 01

Beijing, Beijing Municipality, China

Site Status

Study site 01

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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yue NA Liu

Role: CONTACT

Phone: 010-56456739

Email: [email protected]

Facility Contacts

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yue NA Liu

Role: primary

yue NA Liu

Role: primary

Other Identifiers

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GZR18-BWM-303

Identifier Type: -

Identifier Source: org_study_id