Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

NCT05966272 | Completed Phase 2

• 1 other identifier: HRS9531-202
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c after 20 weeks of treatment

  Week 0 to Week 20

Secondary Outcomes (9)

• Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment

  Week 0 to Week 20

• Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment

  Week 0 to Week 32

• Change From Baseline in HbA1c after 32 weeks

  Week 0 to Week 32

• Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment

  Week 0 to Week 20

• Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment

  Week 0 to Week 32

Study Arms (8)

Treatment group A

EXPERIMENTAL

HRS9531 injection dose level 1

Drug: HRS9531 injection

Treatment group B

EXPERIMENTAL

HRS9531 injection dose level 2

Drug: HRS9531 injection

Treatment group C

EXPERIMENTAL

HRS9531 injection dose level 3

Drug: HRS9531 injection

Treatment group D

EXPERIMENTAL

HRS9531 injection dose level 4

Drug: HRS9531 injection

Treatment group E

PLACEBO COMPARATOR

HRS9531 injection Placebo dose level 1

Drug: HRS9531 injection Placebo

Treatment group F

PLACEBO COMPARATOR

HRS9531 injection Placebo dose level 2

Drug: HRS9531 injection Placebo

Treatment group G

PLACEBO COMPARATOR

HRS9531 injection Placebo dose level 3

Drug: HRS9531 injection Placebo

Treatment group H

PLACEBO COMPARATOR

HRS9531 injection Placebo dose level 4

Drug: HRS9531 injection Placebo

Interventions

HRS9531 injection DRUG

single dose

Treatment group A; Treatment group B; Treatment group C; Treatment group D

HRS9531 injection Placebo DRUG

single dose

Treatment group E; Treatment group F; Treatment group G; Treatment group H

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ,18-65 years of age, agreed and signed the informed consent
• Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
• Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
• HbA1c 7.5-10.5% (both inclusive) at screening visit.

You may not qualify if:

• Presence of any clinically significant results in examination at screening visit.
• Uncontrollable hypertension.
• A history of type 1 diabetes, specific diabetes, or secondary diabetes.
• Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
• History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
• 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.
• Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
• Surgery is planned during the trial.
• Mentally incapacitated or speech-impaired.
• Pregnant or lactating woman.
• In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: August 12, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)