A Study of GZR18 Injection in Obese/Overweight Patients

NCT ID: NCT06256562

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-08
• Study Completion Date: 2024-06-05

Brief Summary

This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GZR18

GZR18 injection s.c.

Group Type: EXPERIMENTAL

GZR18

Intervention Type: DRUG

Titrated to dose 1, dose 2, dose 3 or dose 4

Placebo

Placebo injection s.c.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Administered the same volume as GZR18

Interventions

GZR18

Titrated to dose 1, dose 2, dose 3 or dose 4

Intervention Type: DRUG

Placebo

Administered the same volume as GZR18

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 18-75 years (inclusive).

2. Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI<28 kg/m2) with at least one comorbidity.

3. 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.

Exclusion Criteria

1. Limb deformities or defects affecting height and body weight measurement.

2. Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.

3. History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.

4. Alcohol abuse history within 6 months prior to screening.

5. Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.

6. Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liyuan Zhao, Ph.D

Role: STUDY_DIRECTOR

Gan & Lee Pharmaceuticals.

Locations

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, , China

Countries

China

Other Identifiers

GL-GLP-CH2005

Identifier Type: -

Identifier Source: org_study_id