A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

Launched by GAN & LEE PHARMACEUTICALS. · Dec 10, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called GZR18 Injection for adults who are overweight or obese. The study aims to see how well this injection works and whether it is safe for people with these conditions in China. To participate, individuals must be at least 18 years old and have a body mass index (BMI) that indicates they are overweight or obese, along with at least one related health issue, like high blood pressure or diabetes. Participants should be ready to follow a stable diet and exercise routine during the study and will need to agree to use effective birth control if they could become pregnant.

The trial is not yet recruiting participants, but once it starts, volunteers will be randomly assigned to receive either the GZR18 Injection or a placebo (a treatment that looks the same but has no active ingredients). Throughout the study, participants will be monitored to evaluate their health and any changes in their weight. This trial is an important step in finding new options for managing obesity, which can lead to better health outcomes for many people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.
• • Obese (BMI ≥ 28 kg/m2) or overweight (24 kg/m2 ≤ BMI \< 28 kg/m2) with at least one comorbidity.
• • 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.
• • Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).
• Exclusion Criteria:
• • Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.
• • History of drug abuse prior to screening.
• • History of alcohol abuse within 6 months before screening.
• • Weight change of \> 5.0% within 3 months before screening (self-report).
• • Presence of limb deformity or mutilation affecting height measurement.