the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone

NCT ID: NCT06650007

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-08
• Study Completion Date: 2026-07-31

Brief Summary

The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 24 weeks of treatment

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

Group Type: EXPERIMENTAL

HRS9531 Injection

Intervention Type: DRUG

HRS9531 Injection

Group B

Group Type: PLACEBO_COMPARATOR

HRS9531 Placebo Injection

Intervention Type: DRUG

HRS9531 Placebo Injection

Group C

Group Type: EXPERIMENTAL

HRS9531 Injection

Intervention Type: DRUG

HRS9531 Injection

Group D

Group Type: PLACEBO_COMPARATOR

HRS9531 Placebo Injection

Intervention Type: DRUG

HRS9531 Placebo Injection

Interventions

HRS9531 Injection

HRS9531 Injection

Intervention Type: DRUG

HRS9531 Placebo Injection

HRS9531 Placebo Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and females, Age ≥18 years at the time of signing informed consent.

2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.

3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.

4. 7.5% ≤ HbA1c ≤10.0% at screening.

Exclusion Criteria

1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.

2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.

3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).

4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；

5. Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.

6. Participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

HRS9531-302

Identifier Type: -

Identifier Source: org_study_id