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Overweight or ObesityPhase 3GZR18-BWM-303NCT07292441

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

A Phase 3 study testing GZR18 injection in people with Overweight or Obesity, run by Gan & Lee Pharmaceuticals. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Overweight or Obesity
What is being tested?
GZR18 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
2 sitesChina
Study dates
22 Jan 2026to Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • -

Who cannot join

  • 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.
  • -

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

yue NA Liu contact

010-56456739

yue3.liu@ganlee.com

China2 sites, 2 recruiting

  • Study site 01

    Beijing, Beijing Municipality, Beijing

    yue NA Liu, 010-56456739

    Not yet recruiting

  • Study site 01

    Beijing, Beijing Municipality, Beijing

    yue NA Liu, 010-56456739, yue3.liu@ganlee.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
GZR18 injection, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GZR18 injectionDrug

    Used as specified in the protocol

  • PlaceboOther

    Administered the same volume as GZR18

Study groups in NCT07292441
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
GZR18 injection Dose1ExperimentalNot described
Receives: Drug: GZR18 injection
GZR18 injection Dose2ExperimentalNot described
Receives: Drug: GZR18 injection
GZR18 injection Dose3ExperimentalNot described
Receives: Drug: GZR18 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change (%) from baseline in body weight

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

Secondary outcomes (20)

  1. Changes from baseline in weight;

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

  2. Changes from baseline body mass index (BMI)；

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

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

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

  4. Changes from baseline in hemoglobin A1c (HbA1c) ;

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

  5. Changes from baseline in fasting plasma glucose (FPG);

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

  6. Changes from baseline in blood pressure (SBP and DBP);

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

  7. Changes from baseline in total cholesterol (TC);

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

  8. Changes from baseline in low-density lipoprotein cholesterol (LDL-C);

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

  9. Changes from baseline in high-density lipoprotein cholesterol (HDL-C);

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

  10. Changes from baseline in triglyceride (TG);

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

  11. Changes from baseline in free fatty acids.

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

  12. Treatment-Emergent Adverse Events (TEAEs);

    Measured: from Week 0 (W0) to Week 25 (W25)

  13. Treatment-Emergent Serious Adverse Events (TESAEs);

    Measured: from Week 0 (W0) to Week 25 (W25)

  14. Pulse rate;

    Measured: from Week 0 (W0) to Week 25 (W25)

  15. Lipase;

    Measured: from Week 0 (W0) to Week 25 (W25)

  16. Amylase;

    Measured: from Week 0 (W0) to Week 25 (W25)

  17. Calcitonin

    Measured: from Week 0 (W0) to Week 25 (W25)

  18. The scores of Patient Health Questionnaire-9

    the highest/worst score during the trial (the higher scores mean a worse outcome

    Measured: from Week 0 (W0) to Week 25 (W25)

  19. GZR18 anti-drug antibody (ADA) and neutralizing antibody (NAb);

    Measured: from Week 0 (W0) to Week 25 (W25)

  20. Cross reaction between GZR18 ADA and endogenous glucagon-like peptide-1 (GLP-1).

    Measured: from Week 0 (W0) to Week 25 (W25)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start22 Jan 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07292441
Sponsor's protocol ID
GZR18-BWM-303
Acronym
GZR18-BWM-303
Status last verified
Nov 2025
First submitted
20 Nov 2025
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GZR18 injection in people with Overweight or Obesity, run by Gan & Lee Pharmaceuticals. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact yue NA Liu (010-56456739, yue3.liu@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change (%) from baseline in body weight (time frame: from Week 0 (W0) to Week 24 (W24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07292441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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