A Study of GZR18 Injection in Chinese Obese/Overweight Patients

Obesity Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06256536
• Other study ID #: GL-GLP-CH2002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 14, 2022
• Est. completion date: October 22, 2023

Study information

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

Clinical Trial Summary

The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 22, 2023
• Est. primary completion date: October 22, 2023
• 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 = 28.0 kg/m2; or overweight subjects: 24.0 = BMI < 28.0 kg/m2 with at least one comorbidity;

3. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.

Exclusion Criteria:

• 1. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.

2. Subjects with body weight change > 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.

3. Heart rate < 50 beats/min or > 100 beats/min on 12-lead ECG at screening.

4. Presence of the following clinically significant 12-lead ECG abnormalities at screening.

5. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• GZR18
0.6 mg-30 mg

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	Incidence of adverse events and serious adverse events		38 weeks
Primary	Changes in weight from baseline to the end of treatment		35 weeks
Secondary	trough concentrations following consecutive doses		35 weeks
Secondary	Changes in Body mass index (BMI) from baseline to the end of treatment		35 weeks
Secondary	Changes in Percentage of reduction in weight (%) from baseline to the end of treatment		35 weeks
Secondary	Changes in Waist circumference from baseline to the end of treatment		35 weeks
Secondary	Proportion of subjects with =5% reduction in body weight from baseline.		35 weeks