Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 15, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07877038). This is a study registration, not published results. Lead sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 32 participants (ESTIMATED). Conditions: Obesity, Overweight, T2DM (Type 2 Diabetes Mellitus). Interventions: DRUG: DA-302168S. Primary outcome measures: Peak Plasma Concentration (Cmax) of DA-302168S , Predose up to 72 hours postdose (D1 to D4); Area Under the Serum Concentration Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of DA-302168S , Predose up to 72 hours postdose (D1 to D4). Brief summary: This is an open-label, non-randomized study to assess how DA-302168S is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy subjects matched by gender, age, and body mass index (BMI). It will also explore the relationship between baseline liver function measures and the pharmacokinetic (PK) parameters of DA-302168S, to support appropriate dosing recommendations for patients with liver impairment.