A Study of GZR18 Injection in Chinese Obese/Overweight Patients

NCT06256536 | Completed Phase 1

• 1 other identifier: GL-GLP-CH2002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events and serious adverse events

  38 weeks

• Changes in weight from baseline to the end of treatment

  35 weeks

Secondary Outcomes (5)

• 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

• Changes in Waist circumference from baseline to the end of treatment

  35 weeks

• Proportion of subjects with ≥5% reduction in body weight from baseline.

  35 weeks

Study Arms (2)

GZR18

EXPERIMENTAL

GZR18 injection s.c.

Drug: GZR18

Placebo

PLACEBO COMPARATOR

Placebo injection s.c.

Other: Placebo

Interventions

GZR18 DRUG

0.6 mg-30 mg

GZR18

Placebo OTHER

administered the same volume as GZR18

Placebo

Eligibility Criteria

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

You may qualify if:

• \. Male or female aged 18-65 years (inclusive);
• \. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI \< 28.0 kg/m2 with at least one comorbidity;
• \. 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.

You may not qualify if:

• \. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.
• \. Subjects with body weight change \> 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.
• \. Heart rate \< 50 beats/min or \> 100 beats/min on 12-lead ECG at screening.
• \. Presence of the following clinically significant 12-lead ECG abnormalities at screening.
• \. 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.

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 1
• 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: July 14, 2022
• Primary Completion: October 22, 2023
• Study Completion: October 22, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (1)