A Study of GZR18 Injection in Chinese Obese/Overweight Patients

Gan and Lee Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Overweight

Obesity

Treatments

Other: Placebo

Drug: GZR18

Study type

Interventional

Funder types

Industry

Identifiers

NCT06256536

GL-GLP-CH2002

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.