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NCT Number: NCT06728124

A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.
  • Obese (BMI ≥ 28 kg/m2) or overweight (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.
  • Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).

Exclusion criteria

  • Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.
  • History of drug abuse prior to screening.
  • History of alcohol abuse within 6 months before screening.
  • Weight change of > 5.0% within 3 months before screening (self-report).
  • Presence of limb deformity or mutilation affecting height measurement.

Treatment and study plan

GZR18

Drug

Used as specified in the protocol

Placebo

Other

Administered the same volume as GZR18

Primary outcomes

  1. Percent change in weight from baseline (%)

    Time frame: From Week 0 to Week 48

Secondary outcomes

  1. Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline

    Time frame: From Week 0 to Week 48

  2. Changes from baseline in weight

    Time frame: From Week 0 to Week 48

  3. Changes from baseline in body mass index (BMI)

    Time frame: From Week 0 to Week 48

    weight and height will be combined to report BMI in kg/m^2

  4. Changes from baseline in hip circumference

    Time frame: From Week 0 to Week 48

  5. Changes from baseline in waist circumference

    Time frame: From Week 0 to Week 48

  6. Changes from baseline in waist-hip ratio (waist circumference/hip circumference)

    Time frame: From Week 0 to Week 48

  7. Treatment emergent adverse events (TEAEs)

    Time frame: From Week 0 to Week 48

Sponsors and collaborators

Lead sponsor

Gan & Lee Pharmaceuticals.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Nov 25, 2025

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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