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

NCT06728124 | Active Not Recruiting Phase 3

• 1 other identifier: GZR18-BWM-301
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.

Conditions

Obesity/Overweight

Outcome Measures

Primary Outcomes (1)

• Percent change in weight from baseline (%)

  From Week 0 to Week 48

Secondary Outcomes (7)

• Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline

  From Week 0 to Week 48

• Changes from baseline in weight

  From Week 0 to Week 48

• Changes from baseline in body mass index (BMI)

  From Week 0 to Week 48

• Changes from baseline in hip circumference

  From Week 0 to Week 48

• Changes from baseline in waist circumference

  From Week 0 to Week 48

Study Arms (2)

GZR18

EXPERIMENTAL

Drug: GZR18

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

GZR18 DRUG

Used as specified in the protocol

GZR18

Placebo OTHER

Administered the same volume as GZR18

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Beijing

Beijing, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: December 30, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2024-12

Locations

CN (1)