NCT05966272CompletedPhase 2
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
Source: ClinicalTrials.gov · Last updated 7 May 2025
Brief summary (registry, in English)
To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 199 (actual)
- First submitted
- 21 Jul 2023
- Start date
- 12 Aug 2023
- Primary completion date
- 24 Sept 2024
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05966272
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 199
- From 12 Aug 2023 to the primary completion date, 24 Sept 2024
- 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
- Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
- History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- Surgery is planned during the trial.
Other illness
- Uncontrollable hypertension.
- A history of type 1 diabetes, specific diabetes, or secondary diabetes.
- Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
Other
- Presence of any clinically significant results in examination at screening visit.
- Mentally incapacitated or speech-impaired.
- Pregnant or lactating woman.
- In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Who the study is looking for
- Male or female subjects ,18-65 years of age, agreed and signed the informed consent
- Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
- Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- HbA1c 7.5-10.5% (both inclusive) at screening visit.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.