A Study of GZR18 Injection in Obese/Overweight Patients

NCT06256562 | Completed Phase 2

• 1 other identifier: GL-GLP-CH2005
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Percent (%) change from baseline in body weight at the end of the study (W30)

  30 weeks

Secondary Outcomes (11)

• Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.

  30 weeks

• Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)

  30 weeks

• Percentage (%) of weight

  33 weeks

• Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β)

  30 weeks

• Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG)

  30 weeks

Study Arms (2)

GZR18

EXPERIMENTAL

GZR18 injection s.c.

Drug: GZR18

Placebo

PLACEBO COMPARATOR

Placebo injection s.c.

Other: Placebo

Interventions

GZR18 DRUG

Titrated to dose 1, dose 2, dose 3 or dose 4

GZR18

Placebo OTHER

Administered the same volume as GZR18

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-75 years (inclusive).
• Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI\<28 kg/m2) with at least one comorbidity.
• 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.

You may not qualify if:

• Limb deformities or defects affecting height and body weight measurement.
• 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.
• History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
• Alcohol abuse history within 6 months prior to screening.
• Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
• Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liyuan Zhao, Ph.D

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: June 8, 2023
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: October 1, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)