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

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: HRS9531 Placebo Injection; Drug: HRS9531 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06650007

HRS9531-302

Details and patient eligibility

About

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

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 4 patient groups, including a placebo group

Group A

Experimental group

Treatment:

Drug: HRS9531 Injection

Group B

Placebo Comparator group

Treatment:

Drug: HRS9531 Placebo Injection

Group C

Experimental group

Treatment:

Drug: HRS9531 Injection

Group D

Placebo Comparator group

Treatment:

Drug: HRS9531 Placebo Injection