Last reviewed · How we verify
NCT07285902
A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity
Phase 3 trial testing HRS9531 injection in Obesity in 572 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2027
Quick facts
| Lead sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 572 |
| Start date | 25 December 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 March 2027 |
| Sites | 2 locations across China |
Drugs / interventions tested
- HRS9531 injection
- Semaglutide Injection
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage change from baseline in body weight after 52 weeks of treatment
Time frame: 52 weeks
Sponsor's own description
This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07285902
- 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
- NCT05881837 — Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes · Phase 2 · completed
Other recruiting trials for Obesity
Currently open trials in the same condition.
- NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
- NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
- NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · 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 NCT07285902 (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: 26 February 2026
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/NCT07285902.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing