Metabolic Dysfunction Associated Steatotic Liver Disease/steatohepatitis (MASLD/ / HRS-4729 / Type 2 Diabetes Mellitus · Phase 1 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration for a single-dose pharmacokinetic study of HRS-4729, a candidate therapeutic for metabolic and liver disease, planned in healthy volunteers and patients stratified by degree of renal impairment. No results have been posted; the record describes the protocol only and does not support any clinical inference.
Phase 1, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH), Type 2 Diabetes Mellitus; age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: Group A: control group, comprising healthy Participants wit…; Group B: comprise Participants with mild renal impairment;; Group C: comprise Participants with moderate renal impairme…; Group D: comprise Participants with severe renal impair…. n = 32. 1 site: China.
This is a Phase 1 clinical trial registration for a single-dose pharmacokinetic study of HRS-4729, a candidate therapeutic for metabolic and liver disease, planned in healthy volunteers and patients stratified by degree of renal impairment. No results have been posted; the record describes the protocol only and does not support any clinical inference.
Primary endpoints are pharmacokinetic (Cmax, AUC) and are surrogate measures; clinical efficacy or safety outcomes are not described. No safety or tolerability data are available.
This protocol-only record does not provide evidence to guide clinical practice. Readers should await publication of completed results before any interpretation of HRS-4729 safety or efficacy.
Phase 1 single-dose pharmacokinetic study in a small, planned cohort with no results yet posted; registry record only describes the protocol.
As stated by the source record.
Quoted from the source exactly as published.
This protocol-only record does not provide evidence to guide clinical practice. Readers should await publication of completed results before any interpretation of HRS-4729 safety or efficacy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07807059). This is a study registration, not published results. Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 32 participants (ESTIMATED). Conditions: Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH), Type 2 Diabetes Mellitus. Interventions: DRUG: HRS-4729. Primary outcome measures: Cmax , assessed up to approximately 4 weeks post-dose;; AUC0-t , assessed up to approximately 4 weeks post-dose; AUC0-inf. , assessed up to approximately 4 weeks post-dose. Brief summary: This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8 healthy participants.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.