Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New insulin rival: can GZR4 beat current options for diabetes?

NCT ID NCT07165223

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new insulin drug, GZR4, against another insulin (Insulin Icodec) in 300 adults with type 2 diabetes who already use basal insulin. The goal is to see which one controls blood sugar better and causes fewer side effects like low blood sugar. Participants may also take other diabetes pills during the study.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2026

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

18 years and older

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol. * Males and females age ≥ 18 years at the time of informed consent. * The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative for women of childbearing potential during the screening period and prior to randomization. * From signing the Informed Consent Form until 3 weeks after the end of treatment, female subjects of childbearing potential and male subjects and their partners must agree to use reliable contraceptive measures and not donate eggs (ova, oocytes) or sperm for assisted reproductive purposes. * According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening. * Before screening, basal insulin was given once or twice a day. Or Insulin Icodec was given once-weeekly before screening. Exclusion Criteria: * A history of allergy to drugs with two or more mechanisms of action in the past, or known allergies, hypersensitivity, or intolerance to the investigational medicinal product or its excipients. * Subjects who are pregnant, lactating or planning to become pregnant during the study at screening. * Participated in any drug clinical study (received non-placebo medication during the study) within a recent period of time (90 days or 5 half-lives of the previous investigational medicinal product, whichever is longer), or plans to participate in another clinical study before completing all scheduled assessments in this clinical study. * Underwent invasive cardiovascular or cerebrovascular procedures within 180 days before screening; or experienced acute heart failure, myocardial infarction, stroke, or hospitalization due to angina unstable, transient ischaemic attack, or other acute cardiovascular events within 180 days before screening; or have a history of chronic cardiac failure classified as New York Heart Association Class III or IV at screening; or plan to undergo coronary, carotid, or peripheral arterial revascularisation procedures during the study; or have clinically significant abnormalities on the electrocardiogram (ECG) that the investigator considers inappropriate to participate in this study (such as second-degree type II or third-degree atrioventricular block, ventricular fibrillation, etc.). * History of malignant tumors within 5 years 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. * The patient with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening. * Subjects who are unable to comply with the requirements of this protocol as judged by the investigator, or have any other conditions that the investigator considers inappropriate to participate in this study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetes are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gan & Lee Pharmaceuticals Shandong Co., Ltd.

    RECRUITING

    Linyi, Shandong, 276000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.