the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone

NCT06650007 | Active Not Recruiting Phase 3

• 1 other identifier: HRS9531-302
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 24 weeks of treatment

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  from baseline to 36 weeks treatment

Secondary Outcomes (4)

• Proportion of subjects with HbA1c<7.0% and ≤6.5%

  from baseline to 36 weeks treatment

• Change in FPG

  from baseline to 36 weeks treatment

• Change in body weight

  from baseline to 36 weeks treatment

• Proportion of subjects with HbA1c<7.0% and weight loss ≥5%

  from baseline to 36 weeks treatment

Study Arms (4)

Group A

EXPERIMENTAL

Drug: HRS9531 Injection

Group B

PLACEBO COMPARATOR

Drug: HRS9531 Placebo Injection

Group C

EXPERIMENTAL

Drug: HRS9531 Injection

Group D

PLACEBO COMPARATOR

Drug: HRS9531 Placebo Injection

Interventions

HRS9531 Injection DRUG

HRS9531 Injection

Group A; Group C

HRS9531 Placebo Injection DRUG

HRS9531 Placebo Injection

Group B; Group D

Eligibility Criteria

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

You may qualify if:

• Males and females, Age ≥18 years at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
• Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
• % ≤ HbA1c ≤10.0% at screening.

You may not qualify if:

• Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
• Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
• 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.).
• 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) ；
• Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.
• 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).

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410100, 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: November 8, 2024
• Primary Completion: May 14, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CN (1)