Actively Recruiting
Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss
Led by Gan & Lee Pharmaceuticals. · Updated on 2026-03-11
500
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participated in the original study and completed the last dose at Week 50, end of treatment visit at Week 52, and safety follow-up at Week 55, with last dose at Week 50 being at least 24 mg (including placebo).
- Have a BMI greater than 18.5 kg/m² at Week 55 of the original study and before randomization at Visit 2 of this study, and deemed suitable by the investigator.
- If of childbearing potential, have no plan to become pregnant from signing consent until 8 weeks after the last dose, willing to use effective contraception, and no plan to donate sperm or eggs.
- Non-lactating women of childbearing potential must have a negative pregnancy test before randomization at Visit 2.
- Able to understand study procedures, willing and able to maintain regular diet and exercise during the study, willing to receive subcutaneous injections, and willing to sign informed consent voluntarily.
You will not qualify if you...
- Used Semaglutide (Wegovy) during the original study.
- Have a diagnosis of any type of diabetes mellitus, excluding gestational diabetes.
- Have fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% at Week 52 visit of the original study.
- Plan to participate in another clinical study or receive other treatments affecting body weight before completing this study's assessments.
- Have any other factors that may affect study efficacy or safety as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Study site 01
Beijing, Beijing Municipality, China, Beijing
Not Yet Recruiting
2
Study site 01
Beijing, Beijing Municipality, China, Beijing
Actively Recruiting
Research Team
Y
yue NA Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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