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NCT05152277
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects
Phase 1 trial testing HRS9531 in Type 2 Diabetes in 90 participants. Completed in 24 August 2022.
24 August 2022
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 | basic science |
| Enrollment | 90 |
| Start date | 6 December 2021 |
| Primary completion | 24 August 2022 |
| Estimated completion | 24 August 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- HRS9531
- placebo
- HRS9531
- placebo
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.
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 NCT05152277
- 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 Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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 NCT05152277 (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: 19 September 2022
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/NCT05152277.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing