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CompletedNCT06650007Updated Jul 14, 2026

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

A Phase 3 interventional study of HRS9531 Injection and HRS9531 Placebo Injection in Diabetes Mellitus, Type 2, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 36 weeks of treatment

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 218 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Males and females, Age ≥18 years at the time of signing informed consent.
  2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
  3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
  4. 7.5% ≤ HbA1c ≤10.0% at screening.

Exclusion criteria

Exclusion Criteria:

  1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
  2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
  3. 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.).
  4. 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) ;
  5. Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.
  6. 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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
218 participants (actual)

Study arms

  • Experimental
    Group A

    Drug: HRS9531 Injection

  • Placebo comparator
    Group B

    Drug: HRS9531 Placebo Injection

  • Experimental
    Group C

    Drug: HRS9531 Injection

  • Placebo comparator
    Group D

    Drug: HRS9531 Placebo Injection

Interventions

  • DrugHRS9531 Injection

    HRS9531 Injection

  • DrugHRS9531 Placebo Injection

    HRS9531 Placebo Injection

06

What researchers measure

Primary outcomes

  1. Change in HbA1c

    Time frame: from baseline to 36 weeks treatment

Secondary outcomes

  1. Proportion of subjects with HbA1c<7.0% and ≤6.5%

    Time frame: from baseline to 36 weeks treatment

  2. Change in FPG

    Time frame: from baseline to 36 weeks treatment

  3. Change in body weight

    Time frame: from baseline to 36 weeks treatment

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

    Time frame: from baseline to 36 weeks treatment

07

Study locations

1 site
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan 410100, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06650007
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 21, 2024
Start date
Nov 8, 2024
Primary completion
Jan 21, 2026
Completion
Jun 12, 2026
Last update
Jul 14, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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