New diabetes shot shows promise in Late-Stage trial
NCT ID NCT06777238
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 study tests an injectable drug called GZR18 in 274 Chinese adults with type 2 diabetes whose blood sugar is not well controlled by diet and exercise alone. Participants receive either GZR18 or a placebo to see if the drug improves blood sugar levels, weight, and waist size. The trial is active but not recruiting, and results will help determine if GZR18 is a safe and effective treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GZR18 injection
- What this could lead to
- If successful, this could offer a new injectable option to help people with type 2 diabetes better control their blood sugar and possibly lose weight.
- What could go wrong
- This is a Phase 3 trial, but results may not apply to all populations. Side effects are possible, and the drug may not prove significantly better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
274 people
The number who actually took part.
- Started
-
Jan 2025
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing
Beijing, China
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Other studies related to the condition(s) this trial covers.
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