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OpenTrials
Completed

NCT Number: NCT06650007

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410100, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

HRS9531 injection

Drug

HRS9531 Injection

HRS9531 Placebo Injection

Drug

HRS9531 Placebo Injection

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

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Jul 14, 2026

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.

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