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

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

Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss (NCT07292441) is a Phase 3 interventional studying Overweight or Obesity, sponsored by Gan & Lee Pharmaceuticals.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Overweight or Obesity, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 500 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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. \- Who Should NOT Join This Trial: 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. \- Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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. \-

Treatments Being Tested

DRUG

GZR18 injection

Used as specified in the protocol

OTHER

Placebo

Administered the same volume as GZR18

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Study site 01

Beijing, Beijing Municipality, China

Study site 01

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07292441), the sponsor (Gan & Lee Pharmaceuticals.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07292441 clinical trial studying?

Who can participate in NCT07292441?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07292441?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07292441. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07292441. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.