drugset / Trial / NCT06562907

Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)

NCT06562907 ↗

Phase 1 Recruiting 134 enrolled Gilead Sciences
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-08-28
Primary completion
2026-11
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject GS-4571 Unknown — Oral
Subject Omeprazole Other / unclassified — Oral

Indications

No indication recorded.