A Study of GZR18 Injection in Chinese Obese/Overweight Patients

Phase 1

Completed

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

• Registration Number: NCT06256536
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

Brief Summary

The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Primary Completion: 2023-10-22
• Study Completion: 2023-10-22
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Male or female aged 18-65 years (inclusive);

  2. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI < 28.0 kg/m2 with at least one comorbidity;

  3. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.

Exclusion Criteria

• 1. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.

  2. Subjects with body weight change > 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.

  3. Heart rate < 50 beats/min or > 100 beats/min on 12-lead ECG at screening.

  4. Presence of the following clinically significant 12-lead ECG abnormalities at screening.

  5. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at 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
Incidence of adverse events and serious adverse events	38 weeks
Changes in weight from baseline to the end of treatment	35 weeks

Secondary Outcome Measures

Name	Time	Method
trough concentrations following consecutive doses	35 weeks
Changes in Body mass index (BMI) from baseline to the end of treatment	35 weeks
Changes in Percentage of reduction in weight (%) from baseline to the end of treatment	35 weeks
Proportion of subjects with ≥5% reduction in body weight from baseline.	35 weeks
Changes in Waist circumference from baseline to the end of treatment	35 weeks

Trial Locations

Locations (1)

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