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

Gan & Lee Pharmaceuticals.

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight or Obesity

Treatments: Drug: GZR18 injection; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07292441

GZR18-BWM-303

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

GZR18 injection Dose1

Experimental group

Treatment:

Drug: GZR18 injection

GZR18 injection Dose2

Experimental group

Treatment:

Drug: GZR18 injection

GZR18 injection Dose3

Experimental group

Treatment:

Drug: GZR18 injection