A Study of GZR18 Injection in Obese/Overweight Patients

NCT06256562
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Phase
Phase 2
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Recruitment status
Completed
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Participants
340
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Lead sponsor
Gan and Lee Pharmaceuticals, USA
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Start date
2023-06-08
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Number of sites
1
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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.
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Short title
A Study of GZR18 Injection in Obese/Overweight Patients
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Official title
A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-06-05
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First posted
2024-02-13
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Registry last updated
2025-10-01
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Primary completion date
2024-06-05
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Start date
2023-06-08
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Actual participants
340
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Participants
340
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Gan and Lee Pharmaceuticals, USA
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06256562
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ClinicalTrials.gov ID
NCT06256562
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

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

    Timeframe: 30 weeks

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

    Timeframe: 30 weeks

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

    Timeframe: 30 weeks

    Changes from baseline

  3. Percentage (%) of weight

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 30 weeks

    Changes from baseline

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

    Timeframe: 30 weeks

    Changes from baseline

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

    Timeframe: 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

    Timeframe: 30 weeks

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

    Timeframe: 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

    Timeframe: 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))

    Timeframe: 33 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Gan & Lee Pharmaceuticals Co., LtdBeijing, China
Sources for sites
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Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)