Phase 1 Study Evaluating Safety, Pharmacokinetics, and Food Effects of GS-4571 in Healthy Adults, Obese Non-Diabetics, and Adults With Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the drug GS-4571 to learn about its safety and how it is processed in the body in three groups healthy participants, healthy non-diabetic obese participants, and non-obese participants with Type 2 Diabetes Mellitus T2DM. This Phase 1 clinical trial aims to understand the drugs pharmacokinetics after single and multiple doses and to assess the effects of food and the acid-reducing drug omeprazole on GS-4571s behavior in the body. Participants will be assigned to different groups receiving various doses of GS-4571 or placebo. Initial groups receive single ascending oral doses while fasting to determine the maximum tolerated dose. Another group will evaluate the impact of food and omeprazole on GS-4571. Subsequent groups will receive multiple ascending daily doses for 12 weeks, including obese individuals and those with T2DM, with dosing adjusted based on safety and tolerability findings. During the study, participants will undergo safety assessments and pharmacokinetic measurements up to 96 hours after dosing. Researchers will monitor adverse events, laboratory abnormalities, and changes in body weight for obese participants. The study involves randomization and double-blind masking to compare GS-4571 with placebo. The trial is expected to continue until November 2026, with participant involvement including initial screening, dosing, regular monitoring visits, and safety evaluations throughout the treatment periods.

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