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NCT06650007CompletedPhase 3

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

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
218 (actual)
First submitted
17 Oct 2024
Start date
Nov 2024
Primary completion date
Jan 2026
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
NCT number
NCT06650007

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 218
  • From Nov 2024 to the primary completion date, Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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) ;

Who the study is looking for

  • 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.
  • 7.5% ≤ HbA1c ≤10.0% at screening.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.