Phase 1Recruiting
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
- Sponsor
- Gilead Sciences (Industry)
- Enrolment
- 134 planned
- Conditions
- Weight Management
- Interventions
- GS-4571; Placebo; Omeprazole
- Ages
- adults, older adults
- Registry
- NCT06562907
From the registry
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.
Primary outcomes
- Single-Dose PK Parameter AUCinf of GS-4571
- Single-Dose PK Parameter Cmax of GS-4571
- Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571
- Multiple-Dose Plasma PK Parameter: Cmax of GS-4571