Hengrui Pharmaceuticals SHR-3167 Injection initiates Phase II clinical trial for the treatment of Type 2 diabetes

The Drug Clinical Trial Registration and Information Disclosure Platform shows that a Phase II clinical study has been initiated to evaluate the safety and efficacy of weekly fixed-dose titration and individual dose titration of SHR-3167 in participants with type 2 diabetes and poor blood glucose control who are treated with oral hypoglycemic agents. The trial is randomized, open-label, controlled, and parallel. The registration number is CTR20260971, and the first public disclosure date is March 17, 2026.

The drug formulation is an injection, with a specification of 3ml:150mg per vial. The dosage and administration are to be used according to the protocol, with the treatment schedule also specified in the protocol. The main purpose of this trial is to assess the percentage of participants experiencing at least one hypoglycemic event during 20 weeks of treatment, comparing weekly fixed-dose titration of SHR-3167 versus individual dose titration in participants with type 2 diabetes and poor blood glucose control.

SHR-3167 injection is a biological product indicated for type 2 diabetes. Type 2 diabetes is a common metabolic disorder caused by insulin resistance or insufficient secretion, leading to elevated blood glucose levels. Symptoms include excessive thirst, frequent urination, fatigue, and long-term complications can damage the heart, kidneys, and other organs. Management includes blood sugar control and prevention of complications.

The primary endpoint of this trial is the percentage of participants experiencing at least one hypoglycemic event during 20 weeks of treatment. Secondary endpoints include the event rate of hypoglycemia, the percentage and event rate of Grade 1, Grade 2, and/or Grade 3 hypoglycemic events, and nocturnal hypoglycemia. Additionally, the percentage of time with blood glucose below 3.0 mmol/L during the last two weeks of treatment and the change in HbA1c from baseline after 20 weeks are also measured.

Currently, the trial is ongoing (not yet recruiting), with a target enrollment of 90 participants.

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Editor: Xiao Lang Kuai Bao