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NCT05881837
Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
Phase 2 trial testing HRS9531 injection in Overweight or Obesity in 249 participants. Completed in 13 October 2024.
13 October 2024
Quick facts
| Lead sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 249 |
| Start date | 13 June 2023 |
| Primary completion | 13 October 2024 |
| Estimated completion | 13 October 2024 |
| Sites | 26 locations across China |
Drugs / interventions tested
- HRS9531 injection
- HRS9531 injection
- HRS9531 injection
- HRS9531 injection
- HRS9531 injection Placebo
- HRS9531 injection Placebo
- HRS9531 injection Placebo
- HRS9531 injection Placebo
Conditions studied
- Overweight or Obesity — all drugs for Overweight or Obesity →
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
An Overview of Existing and Emerging Weight-Loss Drugs to Target Obesity-Related Complications: Insights from Clinical Trials.
Kim MK, Kim HS. · · 2025 · cited 4× · PMID 39696983 · DOI 10.4062/biomolther.2024.228
Verify or expand the search:
- PubMed search for NCT05881837
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HRS9531 injection
Trials testing the same drug.
- NCT06792955 — The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution · Phase 1 · completed
- NCT06654960 — Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects · Phase 1 · completed
- NCT06396429 — To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese · Phase 3 · completed
- NCT05966272 — Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects · Phase 2 · completed
Other recruiting trials for Overweight or Obesity
Currently open trials in the same condition.
- NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
- NCT07431086 — Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US · Phase 2 · recruiting
- NCT07294235 — A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants · Phase 1 · recruiting
- NCT07224399 — Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multi · Phase 1 · recruiting
- NCT07170319 — A Study of IBI3032 in Chinese Participants With Overweight or Obesity · Phase 1 · active not 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 NCT05881837 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 30 April 2025
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/NCT05881837.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing