Clinical trial NCT06548945: A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight and Obesity
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: TEAE
timeFrame: 50 days
measure: Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
timeFrame: 50 days
Secondary outcomes:
measure: Cmax
timeFrame: 50 days
measure: AUClast
timeFrame: 50 days
measure: AUC0-inf
timeFrame: 50 days
measure: Tmax
timeFrame: 50 days
measure: λz
timeFrame: 50 days
measure: t1/2
timeFrame: 50 days
measure: tlag
timeFrame: 50 days
measure: CL/F
timeFrame: 50 days
measure: Vz/F
timeFrame: 50 days
measure: AUC%extra
timeFrame: 50 days
measure: MRT
timeFrame: 50 days
measure: Weight
timeFrame: 50 days
measure: Body Mass Index (BMI)
timeFrame: 50 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gan & Lee Pharmaceuticals Co., Ltd
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Liyuan Zhao, Ph.D
role: STUDY_DIRECTOR
References: