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A Study of GZR18 Injection in Obese/Overweight Patients

Phase 2
Completed
Conditions
Obesity
Overweight
Interventions
Other: Placebo
Registration Number
NCT06256562
Lead Sponsor
Gan and Lee Pharmaceuticals, USA
Brief Summary

This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
340
Inclusion Criteria
  1. Male or female aged 18-75 years (inclusive).
  2. Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI<28 kg/m2) with at least one comorbidity.
  3. Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
Exclusion Criteria
  1. Limb deformities or defects affecting height and body weight measurement.
  2. Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.
  3. History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
  4. Alcohol abuse history within 6 months prior to screening.
  5. Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
  6. Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo injection s.c.
GZR18GZR18GZR18 injection s.c.
Primary Outcome Measures
NameTimeMethod
Percent (%) change from baseline in body weight at the end of the study (W30)30 weeks
Secondary Outcome Measures
NameTimeMethod
Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.30 weeks
Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)30 weeks

Changes from baseline

Percentage (%) of weight33 weeks

Change from baseline at the last safety follow-up visit (W33) after discontinuation

Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β)30 weeks

Changes from baseline

Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG)30 weeks

Changes from baseline

Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale30 weeks

Changes from baseline

Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection33 weeks

Changes from baseline

AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min30 weeks
The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study.33 weeks
Vital signs, physical examination, 12-lead Electrocardiogram (ECG), and clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood amylase, blood lipase, coagulation function, calcitonin,TSH/FT3/FT433 weeks

Change from baseline

Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9))33 weeks

Trial Locations

Locations (1)

Gan & Lee Pharmaceuticals Co., Ltd

🇨🇳

Beijing, China

Gan & Lee Pharmaceuticals Co., Ltd
🇨🇳Beijing, China

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