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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06256562
Other study ID # GL-GLP-CH2005
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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