Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 6, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06562907). This is a study registration, not published results. Lead sponsor: Gilead Sciences. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 134 participants (ESTIMATED). Conditions: Weight Management. Interventions: DRUG: GS-4571; DRUG: Placebo; DRUG: Omeprazole. Primary outcome measures: Single-Dose PK Parameter AUCinf of GS-4571 , Up to 96 hours postdose; Single-Dose PK Parameter Cmax of GS-4571 , Up to 96 hours postdose; Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571 , Up to 96 hours postdose; Multiple-Dose Plasma PK Parameter: Cmax of GS-4571 , Up to 96 hours postdose; Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths , Day 1 up to 95 days; Percentage of Participants of Treatment-Emergent Laboratory Abnormalities , Day 1 up to 95 days. Brief summary: The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM). The primary objectives of this study are: * To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571. * To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571. * To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.