NCT07292441 Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss
| NCT ID | NCT07292441 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gan & Lee Pharmaceuticals. |
| Condition | Overweight or Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2026-01-22 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. \- 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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07292441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Overweight or Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07292441 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT07292441 currently recruiting?
Yes, NCT07292441 is actively recruiting participants. Contact the research team at yue3.liu@ganlee.com for enrollment information.
Where is the NCT07292441 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07292441 clinical trial?
NCT07292441 is sponsored by Gan & Lee Pharmaceuticals.. The trial plans to enroll 500 participants.
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