Extension of GZR18 injections to monthly dosing for weight loss maintenance

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

This extension will try giving people who completed a prior GZR18 every-2-weeks treatment a monthly (every 4 weeks) injection for 24 weeks to see if it keeps weight off and is safe.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Gan & Lee Pharmaceuticals. (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07292441 on ClinicalTrials.gov

What this trial studies

This Phase 3 extension enrolls participants who completed the original 52-week GZR18 every-2-weeks program and received a last dose of at least 24 mg. Enrolled subjects will receive subcutaneous injections of either GZR18 or placebo every 4 weeks for 24 weeks while maintaining a regular diet and exercise routine. Body weight and safety measures will be monitored throughout the extension to characterize continued efficacy and adverse events. The study focuses on tolerability of less-frequent dosing and the effect of continued treatment on weight maintenance.

Who should consider this trial

Good fit: Ideal candidates are people who completed the original study through the W55 safety follow-up, had a last dose at W50 of at least 24 mg, have BMI > 18.5 kg/m², and agree to required contraception and lifestyle measures.

Not a fit: People who did not complete the original study, had lower-than-required dosing at study end, are pregnant or breastfeeding, or have contraindications to subcutaneous injections may not benefit or be eligible.

Why it matters

Potential benefit: If successful, monthly GZR18 dosing could help maintain weight loss with fewer injections and potentially improve convenience and adherence.

How similar studies have performed: Other weight-loss injectable programs have used less-frequent maintenance dosing with mixed but sometimes positive results, while GZR18-specific long-term monthly data remain limited.

Eligibility criteria

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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Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Study site 01 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Study site 01 — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: yue NA Liu

Conditions Overweight or Obesity