Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

NCT07060456 | Recruiting Phase 3

• 1 other identifier: HRS9531-305
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c after 40 weeks of treatment.

  from baseline to Week 40

Secondary Outcomes (4)

• Proportion of subjects reaching HbA1<7.0%

  from baseline to Week 40

• Proportion of subjects reaching HbA1≤6.5%

  from baseline to Week 40

• Change in FPG

  from baseline to Week 40

• Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score

  From baseline to Week 40

Study Arms (3)

Treatment group A: HRS9531-low dose

EXPERIMENTAL

Drug: HRS9531

Treatment group B: HRS9531-high dose

EXPERIMENTAL

Drug: HRS9531

Treatment group C

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS9531 DRUG

HRS9531-low dose

Treatment group A: HRS9531-low dose

Placebo DRUG

Placebo

Treatment group C

Eligibility Criteria

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

You may qualify if:

• Male or female, able and willing to provide a written informed consent
• Diagnosed with type 2 diabetes ≥ 90 days；
• On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;
• HbA1c was 7.5%\~11.0% (both inclusive);
• Body Mass Index (BMI) ≥22 kg/m2 at screening.

You may not qualify if:

• A history of type 1 diabetes, specific diabetes, or secondary diabetes;
• Have a history of severe hypoglycemia within t180 days prior to screening;
• History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；
• Have a history of malignancy within 5 years;
• Known or suspected allergy or intolerance to the investigational medicinal products or related products;
• Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;
• Any conditions that the Investigator judges might not be suitable to participate in the trial.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Perking University Peoples' Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hong Chen

CONTACT

+86-0518-82342973; hong.chen@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 11, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-04

Locations

CN (1)