A Study of GZR18 Injection in Chinese Obese/Overweight Patients

February 22, 2024 updated by: Gan and Lee Pharmaceuticals, USA

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 Obese/Overweight Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 ≥ 28.0 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GZR18
GZR18 injection s.c.
Drug: GZR18
0.6 mg-30 mg
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
Incidence of adverse events and serious adverse events
Time Frame: 38 weeks
38 weeks
Changes in weight from baseline to the end of treatment
Time Frame: 35 weeks
35 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gan and Lee Pharmaceuticals, USA

Investigators

  • Study Director: Liyuan Zhao, Ph.D, Gan & Lee Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Actual)

October 22, 2023

Study Completion (Actual)

October 22, 2023

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

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL-GLP-CH2002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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