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

NCT07292441 | Recruiting Phase 3

• 1 other identifier: GZR18-BWM-303
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• Percent change (%) from baseline in body weight

  from Week 0 (W0) to Week 24 (W24)

Secondary Outcomes (20)

• Changes from baseline in weight;

  from Week 0 (W0) to Week 24 (W24)

• Changes from baseline body mass index (BMI)；

  from Week 0 (W0) to Week 24 (W24)

• Changes from baseline in waist circumference, hip circumference, and waist-hip ratio (waist circumference/hip circumference)；

  from Week 0 (W0) to Week 24 (W24)

• Changes from baseline in hemoglobin A1c (HbA1c) ;

  from Week 0 (W0) to Week 24 (W24)

• Changes from baseline in fasting plasma glucose (FPG);

  from Week 0 (W0) to Week 24 (W24)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Other: Placebo

GZR18 injection Dose1

EXPERIMENTAL

Drug: GZR18 injection

GZR18 injection Dose2

EXPERIMENTAL

Drug: GZR18 injection

GZR18 injection Dose3

EXPERIMENTAL

Drug: GZR18 injection

Interventions

Placebo OTHER

Administered the same volume as GZR18

Placebo

GZR18 injection DRUG

Used as specified in the protocol

GZR18 injection Dose1; GZR18 injection Dose2; GZR18 injection Dose3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• Subjects who used Semaglutide (Wegovy®) in the original study.
• Subjects with a previous diagnosis of any type of diabetes mellitus (excluding gestational diabetes mellitus).
• Subjects with FPG ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the central laboratory test at W52 visit of the original study.
• 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.
• 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.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (2)

Study site 01

Beijing, Beijing Municipality, Beijing, China

NOT YET RECRUITING

Study site 01

Beijing, Beijing Municipality, Beijing, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

yue NA Liu

CONTACT

010-56456739; yue3.liu@ganlee.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 18, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-11

Locations

CN (2)