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NCT Number: NCT06256536

A Study 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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.

Exclusion criteria

  • 1. 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.

Treatment and study plan

GZR18

Drug

0.6 mg-30 mg

Placebo

Other

administered the same volume as GZR18

Primary outcomes

  1. Incidence of adverse events and serious adverse events

    Time frame: 38 weeks

  2. Changes in weight from baseline to the end of treatment

    Time frame: 35 weeks

Secondary outcomes

  1. trough concentrations following consecutive doses

    Time frame: 35 weeks

  2. Changes in Body mass index (BMI) from baseline to the end of treatment

    Time frame: 35 weeks

  3. Changes in Percentage of reduction in weight (%) from baseline to the end of treatment

    Time frame: 35 weeks

  4. Changes in Waist circumference from baseline to the end of treatment

    Time frame: 35 weeks

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

    Time frame: 35 weeks

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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