A Study of GZR18 Injection in Obese/Overweight Patients

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

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.

• Inclusion Criteria:

  1. Male or female aged 18-75 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.