Skip to main content
OpenTrials
Completed

NCT Number: NCT05966272

Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HRS9531 injection

Drug

single dose

HRS9531 injection Placebo

Drug

single dose

Primary outcomes

  1. Change From Baseline in HbA1c after 20 weeks of treatment

    Time frame: Week 0 to Week 20

Secondary outcomes

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

    Time frame: Week 0 to Week 20

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

    Time frame: Week 0 to Week 32

  3. Change From Baseline in HbA1c after 32 weeks

    Time frame: Week 0 to Week 32

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

    Time frame: Week 0 to Week 20

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

    Time frame: Week 0 to Week 32

  6. Change from baseline body Weight and waist circumference after 20 weeks of treatment

    Time frame: Week 0 to Week 20

  7. Change from baseline in body Weight and waist circumference after 32 weeks of treatment

    Time frame: Week 0 to Week 32

  8. Number of Participants With Anti-HRS9531 Antibody

    Time frame: Week 0 to Week 36

  9. Number of AEs During the Trial

    Time frame: Week 0 to Week 36

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.