Active — Not RecruitingPhase 3

A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise

China274 participantsStarted 2025-01-16

Plain-language summary

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 (as of the date of signing the Informed Consent Form (ICF)), male or female.
✓. T2DM is diagnosed for at least 8 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).
✓. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, 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 baseline.
✓. Fully understand the purpose, nature, methods, and possible adverse drug reactions (ADRs) of the study, be able to communicate well with the investigator, can understand and comply with the requirements specified in this study, can maintain a regular diet and exercise lifestyle during the study, and voluntarily sign the ICF to enter the study.

Exclusion criteria

✕. Poor compliance during the run-in period as assessed by the investigator.
✕. Known or suspected to be allergic to GLP-1R agonists or their excipients, or have contraindications to their use.

What they're measuring

Primary Outcome Measure

Timeframe: Baseline, Week 44

Trial details

NCT IDNCT06777238

SponsorGan & Lee Pharmaceuticals.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-07

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials