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NCT05516966
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
Phase 1 trial testing HRS9531 in Diabetes Mellitus, Type 2 in 64 participants. Completed in 24 May 2023.
24 May 2023
Quick facts
| Lead sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 12 October 2022 |
| Primary completion | 24 May 2023 |
| Estimated completion | 24 May 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- HRS9531
- Placebo
- Dulaglutide Injection — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05516966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HRS9531
Trials testing the same drug.
- NCT06723691 — Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healt · Phase 1 · completed
- NCT06435676 — A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects · Phase 1 · completed
- NCT06246175 — A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects · Phase 1 · unknown
- NCT06287437 — HRS9531 Controls Weight Regain in Obese Subjects · Phase 2 · unknown
- NCT05893576 — A Relative Bioavailability Study of HRS9531 in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
- NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Fujian Shengdi Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06855147 — Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects · Phase 1 · completed
- NCT06841445 — Efficacy and Safety of HRS9531 Tablet in Obese Subjects · Phase 2 · completed
- NCT06792955 — The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution · Phase 1 · completed
- NCT06723691 — Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healt · Phase 1 · completed
- NCT06732154 — A Phase I Clinical Study of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05516966 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fujian Shengdi Pharmaceutical Co., Ltd.
- Last refreshed: 15 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05516966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing