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

G

Gan and Lee Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Overweight and Obesity

Treatments

Drug: GZR18
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06548945
GL-GLP-CH1017

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

16 participants in 2 patient groups, including a placebo group

GZR18
Experimental group
Treatment:
Drug: GZR18
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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