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NCT05759897
A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus
Phase 2 trial testing HRS-7535 in Type 2 Diabetes in 180 participants. Status unknown.
21 December 2023
Quick facts
| Lead sponsor | Shandong Suncadia Medicine Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 180 |
| Start date | 28 February 2023 |
| Primary completion | 21 December 2023 |
| Estimated completion | 4 January 2024 |
Drugs / interventions tested
- HRS-7535
- Placebo
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Shandong Suncadia Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Small-Molecule GLP-1 Receptor Agonists: A Promising Pharmacological Approach.
Șeremet OC, Pușcașu C, Andrei C, Nițulescu G, et al · · 2025 · cited 1× · PMID 41303737 · DOI 10.3390/medicina61111902 -
HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial.
Guo L, Sun Z, Zhang L, Qin G, et al · · 2026 · PMID 42234428 · DOI 10.1001/jamanetworkopen.2026.15622
Verify or expand the search:
- PubMed search for NCT05759897
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HRS-7535
Trials testing the same drug.
- NCT06671821 — Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects · Phase 2 · completed
- NCT06415214 — Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes · Phase 2 · completed
- NCT06393348 — Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i. · Phase 2 · completed
- NCT05347758 — A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinet · Phase 1 · unknown
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 Shandong Suncadia Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07272330 — A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Subjects · Phase 1 · completed
- NCT07269756 — A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese · Phase 1 · completed
- NCT07229560 — A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants · Phase 1 · completed
- NCT07097831 — A Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects · Phase 1 · completed
- NCT06961643 — Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function · 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 NCT05759897 (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 Shandong Suncadia Medicine Co., Ltd.
- Last refreshed: 8 March 2023
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/NCT05759897.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing