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NCT06731868
Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
Phase 1, PHASE2 trial testing LPM3770164 sustained release tablet 5 mg in Tardive Dyskinesia (TD) in 120 participants. Currently enrolling.
31 October 2025
Quick facts
| Lead sponsor | Luye Pharma Group Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 14 January 2025 |
| Primary completion | 31 October 2025 |
| Estimated completion | 31 October 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- LPM3770164 sustained release tablet 5 mg — full drug profile →
- LPM3770164 sustained release tablet 10 mg — full drug profile →
- LPM3770164 sustained release tablet 20 mg — full drug profile →
- LPM3770164 sustained release tablet simulant — full drug profile →
Conditions studied
- Tardive Dyskinesia (TD) — all drugs for Tardive Dyskinesia (TD) →
Sponsor
Luye Pharma Group Ltd. — full company profile →
Who can join
Adults 18 to 64, any sex, with Tardive Dyskinesia (TD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets in TD patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06731868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Luye Pharma Group Ltd. trials
Trials by the same sponsor.
- NCT07516899 — Mass Balance Study of [14C] LPM3770164 in Healthy Participants · Phase 1 · not yet recruiting
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- NCT07396870 — A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia · Phase 2 · not yet recruiting
- NCT07371065 — To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Sub · Phase 1 · enrolling by invitation
- NCT07230652 — A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020 · Phase 1 · recruiting
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 NCT06731868 (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 Luye Pharma Group Ltd.
- Last refreshed: 22 January 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/NCT06731868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing