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

NCT06548945 | Completed Phase 1

• 1 other identifier: GL-GLP-CH1017
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• TEAE

  Incidence of Treatment Emergent Adverse Event(s)

  50 days

• Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)

  50 days

Secondary Outcomes (13)

• Cmax

  50 days

• AUClast

  50 days

• AUC0-inf

  50 days

• Tmax

  50 days

• λz

  50 days

Study Arms (2)

GZR18

EXPERIMENTAL

Drug: GZR18

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

GZR18 DRUG

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

GZR18

Placebo OTHER

administered the same volume as GZR18

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects sign the informed consent form (ICF) voluntarily.
• Chinese adult subjects, both male and female.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Liyuan Zhao, Ph.D

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: April 25, 2023
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CN (1)