A Study of GZR18 Injection in Obese/Overweight Patients

Gan and Lee Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Overweight

Obesity

Treatments

Drug: GZR18

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06256562

GL-GLP-CH2005

Details and patient eligibility

About

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.

Enrollment

340 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.