A Study of GZR18 Injection in Obese/Overweight Patients

A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: GZR18; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Gan & Lee Pharmaceuticals Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GZR18; GZR18 injection s.c.	Drug: GZR18; Titrated to dose 1, dose 2, dose 3 or dose 4
Placebo Comparator: Placebo; Placebo injection s.c.	Other: Placebo; Administered the same volume as GZR18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent (%) change from baseline in body weight at the end of the study (W30)	30 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA
• Investigators: Study Director: Liyuan Zhao, Ph.D, Gan & Lee Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): July 3, 2024
• Study Completion (Estimated): July 3, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: GL-GLP-CH2005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No