A Study of GZR18 Injection in Obese/Overweight Patients

Obesity Clinical Trial

Official title:

A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06256562
• Other study ID #: GL-GLP-CH2005
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 8, 2023
• Est. completion date: July 3, 2024

Study information

• Verified date: January 2024
• Source: Gan and Lee Pharmaceuticals, USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 340
• Est. completion date: July 3, 2024
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

• Inclusion Criteria:

1. Male or female aged 18-65 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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• GZR18
Titrated to dose 1, dose 2, dose 3 or dose 4

Other:
• Placebo
Administered the same volume as GZR18

Locations

Country	Name	City	State
China	Gan & Lee Pharmaceuticals Co., Ltd	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Gan and Lee Pharmaceuticals, USA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent (%) change from baseline in body weight at the end of the study (W30)		30 weeks
Secondary	Proportion of subjects who achieved (yes/no) body weight reduction =5%, 10%, 15%, 20% from baseline.		30 weeks
Secondary	The number of adverse events (AEs)that occurred during the study.		33 weeks
Secondary	steady-state trough plasma concentration (Css_min)		30 weeks