Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
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…
Conditions studied
Weight Management
About this study
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.
Interventions
- Drug: GS-4571 — Administered orally
- Drug: Placebo — Administered orally
- Drug: Omeprazole — Administered orally
Primary outcomes
- 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)
Eligibility information
Study locations
- Qps-Mra, Llc., Miami, Florida 33143 United States
- ICON Early Phase Services, LLC, San Antonio, Texas 78232 United States
- ICON, Salt Lake City, Utah 84124 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.