Evaluating HRS9531 Injection for Type 2 Diabetes Management

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone

This study is testing if an injection called HRS9531 can help adults with type 2 diabetes better control their blood sugar when diet and exercise aren't enough.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06650007 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of HRS9531 injection in individuals with type 2 diabetes who have not achieved adequate control through diet and exercise alone. Participants will receive either the HRS9531 injection or a placebo over a 24-week period, with the primary focus on measuring changes in blood glucose levels. The study will include adults aged 18 and older who have been diagnosed with type 2 diabetes for at least 90 days and have specific HbA1c levels. The trial seeks to determine if HRS9531 can provide better glycemic control compared to no active treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 2 diabetes inadequately controlled by diet and exercise, and with HbA1c levels between 7.5% and 10.0%.

Not a fit: Patients with type 1 diabetes or those with significant hematological or endocrine disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients struggling to manage their type 2 diabetes with lifestyle changes alone.

How similar studies have performed: Other studies have shown promise in using similar injectable treatments for type 2 diabetes, indicating potential for success with this approach.

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).

Where this trial is running

Changsha, Hunan

• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Guangming Feng

Conditions Diabetes Mellitus, Type 2