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NCT Number: NCT06256562

A Study of GZR18 Injection in Obese/Overweight Patients

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Male or female aged 18-75 years (inclusive).
  • Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI<28 kg/m2) with at least one comorbidity.
  • 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:
  • Limb deformities or defects affecting height and body weight measurement.
  • 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.
  • History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
  • Alcohol abuse history within 6 months prior to screening.
  • Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
  • Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.

Treatment and study plan

GZR18

Drug

Titrated to dose 1, dose 2, dose 3 or dose 4

Placebo

Other

Administered the same volume as GZR18

Primary outcomes

  1. Percent (%) change from baseline in body weight at the end of the study (W30)

    Time frame: 30 weeks

Secondary outcomes

  1. Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.

    Time frame: 30 weeks

  2. Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)

    Time frame: 30 weeks

    Changes from baseline

  3. Percentage (%) of weight

    Time frame: 33 weeks

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

  4. 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)

    Time frame: 30 weeks

    Changes from baseline

  5. 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)

    Time frame: 30 weeks

    Changes from baseline

  6. Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale

    Time frame: 30 weeks

    Changes from baseline

  7. Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection

    Time frame: 33 weeks

    Changes from baseline

  8. AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min

    Time frame: 30 weeks

  9. The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study.

    Time frame: 33 weeks

  10. 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/FT4

    Time frame: 33 weeks

    Change from baseline

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

    Time frame: 33 weeks

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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