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Optimum 1

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

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

274

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

Primary Outcome Measure

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06777238
Org study IDGZR18-T2DM-301

Timeline

Milestones

Study first posted2025-01-15actual
Study start2025-01-16actual
Last update posted2025-11-25actual
Primary completion2026-08-07estimated
Study completion2027-03-10estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age ≥ 18 (as of the date of signing the Informed Consent Form (ICF)), male or female.

2. 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).

3. 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.

4. 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

1. Poor compliance during the run-in period as assessed by the investigator.

2. 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.-

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
3
Other (unclassified)
2

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change in weight(Kg).

Time frame:Baseline, Week 44

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI(kg/m2).

Time frame:Baseline, Week 44

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference(cm).

Time frame:Baseline, Week 44

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Baseline, Week 44

descriptive

Secondary/protocol endpoint/low confidence

Change in hip circumference(cm).

Time frame:Baseline, Week 44

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.