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Completed

NCT Number: NCT06548945

A Phase I Study of GZR18 Injection in Obese/Overweight Subjects

This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

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

  • Subjects sign the informed consent form (ICF) voluntarily.
  • Chinese adult subjects, both male and female.
  • 18 to 65 years old (including both ends) at screening.
  • BMI≥26.0 kg/m2 at screening.
  • Stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening).
  • Female subjects have negative serum Human Chorionic Gonadotropin (HCG) during screening and baseline periods.
  • Subjects have good daily habits and can maintain good communication with investigators and comply with various requirements of clinical trials.

Exclusion criteria

  • Lactating women.
  • History of fainting with blood and needles.
  • Known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history.
  • Subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening.
  • History of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine).
  • Smokers who smoke ≥ 5 cigarettes per day within the previous 3 months before screening or cannot refrain from smoking throughout the trial period.
  • Any vaccine has been used within 28 days before administration, as well as any vaccine that may be used throughout the trial period.
  • Other scenarios judged by the investigator to render the subjects unsuitable for participating in this study.

Treatment and study plan

GZR18

Drug

5 mg-maximum tolerated dose (MTD), single dose

Placebo

Other

administered the same volume as GZR18

Primary outcomes

  1. TEAE

    Time frame: 50 days

    Incidence of Treatment Emergent Adverse Event(s)

  2. Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)

    Time frame: 50 days

Secondary outcomes

  1. Cmax

    Time frame: 50 days

    Maximum plasma drug concentration

  2. AUClast

    Time frame: 50 days

    area under the curve from 0 through the time of the last accurately measurable concentration

  3. AUC0-inf

    Time frame: 50 days

    area under the curve extrapolated to infinity

  4. Tmax

    Time frame: 50 days

    time to maximum plasma drug concentration

  5. λz

    Time frame: 50 days

    elimination rate constant

  6. t1/2

    Time frame: 50 days

    half-life

  7. tlag

    Time frame: 50 days

    lag time

  8. CL/F

    Time frame: 50 days

    apparent clearance

  9. Vz/F

    Time frame: 50 days

    volume of distribution/F

  10. AUC%extra

    Time frame: 50 days

    percent of AUC0-inf extrapolated

  11. MRT

    Time frame: 50 days

    mean residence time

  12. Weight

    Time frame: 50 days

  13. Body Mass Index (BMI)

    Time frame: 50 days

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2024
Registry last updated
Aug 14, 2024

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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