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

NCT06777238 | Active Not Recruiting Phase 3

• 1 other identifier: GZR18-T2DM-301
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

GLP-1RA

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Change in HbA1c

  Baseline, Week 44

Secondary Outcomes (4)

• Change in weight（Kg）.

  Baseline, Week 44

• Change in BMI（kg/m2）.

  Baseline, Week 44

• Change in waist circumference(cm).

  Baseline, Week 44

• Change in hip circumference(cm).

  Baseline, Week 44

Study Arms (3)

GZR18 Dose1

EXPERIMENTAL

Participants will receive GZR18 subcutaneously (SC).

Drug: GZR18

GZR18 Dose 2

EXPERIMENTAL

Participants will receive GZR18 subcutaneously (SC).

Drug: GZR18

placebo group

PLACEBO COMPARATOR

Participants will receive placebo subcutaneously (SC).

Drug: Placebo

Interventions

GZR18 DRUG

Administered SC

GZR18 Dose 2; GZR18 Dose1

Placebo DRUG

Administered SC

placebo group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• （3)Systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at screening or before randomization (concomitant antihypertensive drugs are allowed).
• （4）Have the following cardiovascular and cerebrovascular diseases within 6 months before screening: Decompensated cardiac insufficiency (New York Heart Association NYHA Class III or IV), angina unstable or myocardial infarction, history of heart valve replacement surgery, coronary artery bypass grafting or other invasive cardiovascular surgery including percutaneous coronary intervention, ischemic or hemorrhagic stroke (excluding lacunar infarction), or transient ischemic attack.
• （5）History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
• （6）History of malignant tumors before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) or the presence of underlying malignancy at screening.
• （7）Participated in any drug clinical study (received non-placebo medication during the study) within a period of time before randomization (90 days or 5 half-lives of the previous IMP, whichever is longer), or plan to participate in another clinical study before completing all scheduled assessments in this clinical study.
• （8）Subjects with any other factors that may affect the efficacy or safety evaluation of this study as judged by the investigator.-

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Beijing

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 15, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): August 7, 2026
• Study Completion (Estimated): March 10, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)