A Study Comparing Safety and Efficacy of SHR-3167 Fixed-Dose Titration and Individualized-Dose Titration in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents

NCT07472725 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-3167-203
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The percentage of participants who experienced at least one hypoglycemic event.

  From the baseline to 20-weeks treatment.

Secondary Outcomes (4)

• The event rate of hypoglycemic events.

  From the baseline to 20-weeks treatment.

• Change in glycosylated hemoglobin (HbA1c) from baseline.

  From the baseline to 20-weeks treatment.

• Change in fasting plasma glucose (FPG) from baseline.

  From the baseline to 20-weeks treatment.

• The relative change in HbA1c after 20-weeks treatment compared to the baseline level.

  From the baseline to 20-weeks treatment.

Study Arms (2)

SHR-3167 fixed-dose titration group

EXPERIMENTAL

Drug: SHR-3167 Injection; Drug: SHR-3167 Injection Placebo

SHR-3167 individualized-dose titration group

EXPERIMENTAL

Drug: SHR-3167 Injection; Drug: SHR-3167 Injection Placebo

Interventions

SHR-3167 Injection DRUG

SHR-3167 injection.

SHR-3167 fixed-dose titration group; SHR-3167 individualized-dose titration group

SHR-3167 Injection Placebo DRUG

SHR-3167 injection placebo.

SHR-3167 fixed-dose titration group; SHR-3167 individualized-dose titration group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18-65 years old at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to day of screening.
• During the screening process, at least one of the oral antihyperglycemic agents must be used (no more than 3 types), and the treatment must be stable for at least 2 months.
• Female participants of childbearing potential and their partners are male participants of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 4 months after signing the informed consent form and have no plans to donate eggs/sperm; Female participants of childbearing potential have a negative pregnancy test during the screening period and are not lactating.

You may not qualify if:

• Uncontrollable hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
• Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
• Known or suspected allergy or intolerance to the test drug or excipient.
• There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
• There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases.
• Malignancy within 5 years prior to screening or high risk of recurrence.
• Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
• Participated in clinical trials of any drug or medical device within 3 months prior to screening.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210003, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a Phase II clinical trial to evaluate the safety and efficacy of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: April 11, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

CN (2)