Clinical trial NCT05966272: Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-28
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in HbA1c after 20 weeks of treatment
timeFrame: Week 0 to Week 20
Secondary outcomes:
measure: Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
timeFrame: Week 0 to Week 20
measure: Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
timeFrame: Week 0 to Week 32
measure: Change From Baseline in HbA1c after 32 weeks
timeFrame: Week 0 to Week 32
measure: Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
timeFrame: Week 0 to Week 20
measure: Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
timeFrame: Week 0 to Week 32
measure: Change from baseline body Weight and waist circumference after 20 weeks of treatment
timeFrame: Week 0 to Week 20
measure: Change from baseline in body Weight and waist circumference after 32 weeks of treatment
timeFrame: Week 0 to Week 32
measure: Number of Participants With Anti-HRS9531 Antibody
timeFrame: Week 0 to Week 36
measure: Number of AEs During the Trial
timeFrame: Week 0 to Week 36
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
References: