SHR-3167 steady-state effects in adults with type 2 diabetes.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial measures the pharmacokinetics (PK) and pharmacodynamics (PD) of SHR-3167 at steady state in adults with type 2 diabetes. Participants will receive SHR-3167 injection, with insulin degludec used per protocol as applicable, and will have serial blood sampling for drug levels and glucose-related biomarkers. The study enrolls adults aged 18–59 with a diagnosis of type 2 diabetes for at least six months and includes active safety monitoring for adverse events and laboratory changes. The trial is sponsored by Jiangsu HengRui Medicine Co., Ltd. and conducted at West China Hospital of Sichuan University in Chengdu.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Informed consent obtained before any trial-related activities.
2. Age 18\~59 years at screening (including cut-off values at both ends).
3. Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening.
4. Female subjects of childbearing potential and their partners are male subjects of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 3 months after signing the informed consent form and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.

Exclusion Criteria:

1. Poor blood pressure control at screening.
2. Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods.
3. Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening.
4. Positive test for hepatitis B surface antigen (HBsAg), HIV antibody, treponema pallidum specific antibody, or hepatitis C virus antibody; or the investigator judges that the subject is in the incubation or active phase of the above infection.
5. Malignancy or history of malignancy within 5 years prior to screening.
6. Participation in any clinical trial of an approved or unapproved investigational drug/medical device within 90 days prior to screening.
7. Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Han Jianting
• Email: jianting.han.jh27@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.