A Study of GZR18 Injection in Obese/Overweight Patients

Phase 2

Completed

• Conditions: Obesity; Overweight
• Interventions: Other: Placebo; Drug: GZR18

• Registration Number: NCT06256562
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo injection s.c.
GZR18	GZR18	GZR18 injection s.c.

Primary Outcome Measures

Name	Time	Method
Percent (%) change from baseline in body weight at the end of the study (W30)	30 weeks

Secondary Outcome Measures

Name	Time	Method
The number of adverse events (AEs)that occurred during the study.	33 weeks
steady-state trough plasma concentration (Css_min)	30 weeks
Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.	30 weeks

Trial Locations

Locations (1)

Gan & Lee Pharmaceuticals Co., Ltd; 🇨🇳 Beijing, China