NCT06562907

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

A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Oral Doses of GS-4571 in Healthy Participants, Multiple Ascending Oral Doses of GS-4571 in Nondiabetic Obese Participants and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM), and to Evaluate the Effect of Food and an Acid-Reducing Agent on Pharmacokinetics of GS-4571

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Weight Management

Interventions

Type	Name	Description
DRUG	GS-4571	Administered orally
DRUG	Placebo	Administered orally
DRUG	Omeprazole	Administered orally

Timeline

• Start date: 2024-08-28
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-08-20
• Last updated: 2026-03-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study