Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Type 2 Diabetes Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05966272
• Other study ID #: HRS9531-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 12, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: December 2023
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 199
• Est. completion date: August 20, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects ,18-65 years of age, agreed and signed the informed consent

2. Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.

3. Treated with conventional lifestyle intervention and stable treatment with metformin (=1000 mg/day) at least 8 weeks prior to screening.

4. HbA1c 7.5-10.5% (both inclusive) at screening visit.

Exclusion Criteria:

1. Presence of any clinically significant results in examination at screening visit.

2. Uncontrollable hypertension.

3. A history of type 1 diabetes, specific diabetes, or secondary diabetes.

4. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.

5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.

6. Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.

7. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.

8. Surgery is planned during the trial.

9. Mentally incapacitated or speech-impaired.

10. Pregnant or lactating woman.

11. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• HRS9531 injection
single dose
• HRS9531 injection Placebo
single dose

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c after 20 weeks of treatment		Week 0 to Week 20
Secondary	Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment		Week 0 to Week 20
Secondary	Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment		Week 0 to Week 32
Secondary	Change From Baseline in HbA1c after 32 weeks		Week 0 to Week 32
Secondary	Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment		Week 0 to Week 20
Secondary	Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment		Week 0 to Week 32
Secondary	Change from baseline body Weight and waist circumference after 20 weeks of treatment		Week 0 to Week 20
Secondary	Change from baseline in body Weight and waist circumference after 32 weeks of treatment		Week 0 to Week 32
Secondary	Number of Participants With Anti-HRS9531 Antibody		Week 0 to Week 36
Secondary	Number of AEs During the Trial		Week 0 to Week 36