Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss
ConditionOverweight or Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGan & Lee Pharmaceuticals.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GZR18 injection
DrugUsed as specified in the protocol
Placebo
Other interventionAdministered the same volume as GZR18
Treatment groups
500 Participants
are divided into 4 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: GZR18 injection Dose1Experimental treatment 1 intervention
Group C: GZR18 injection Dose2Experimental treatment 1 intervention
Group D: GZR18 injection Dose3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent change (%) from baseline in body weight
Time frame
from Week 0 (W0) to Week 24 (W24)Secondary outcomes
1
Changes from baseline in weight;
Time frame
from Week 0 (W0) to Week 24 (W24)2
Changes from baseline body mass index (BMI)；
Time frame
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)；
Time frame
from Week 0 (W0) to Week 24 (W24)4
Changes from baseline in hemoglobin A1c (HbA1c) ;
Time frame
from Week 0 (W0) to Week 24 (W24)Sponsors and contacts
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Source ClinicalTrials.gov