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Clinical Trial Details

Trial ID: L6225
Source ID: NCT06562907
Associated Drug: Gs-4571
Title: Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Weight Management
Interventions: DRUG: GS-4571|DRUG: Placebo|DRUG: Omeprazole
Outcome Measures: Primary: Single-Dose PK Parameter AUCinf of GS-4571, AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time., Up to 96 hours postdose|Single-Dose PK Parameter Cmax of GS-4571, Cmax is defined as the maximum observed concentration of drug in plasma., Up to 96 hours postdose|Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571, AUCtau is defined as area under the concentration versus time curve over the dosing interval., Up to 96 hours postdose|Multiple-Dose Plasma PK Parameter: Cmax of GS-4571, Cmax is defined as the maximum observed concentration of drug in plasma., 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 | Secondary: Percentage Change From Baseline (CFB) in Body Weight in Nondiabetic Obese Participants, Day 1 up to 95 days
Sponsor/Collaborators: Sponsor: Gilead Sciences
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 134
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2026-07
Results First Posted:
Last Update Posted: 2024-11-21
Locations: ICON Early Phase Services, LLC, San Antonio, Texas, 78209, United States|ICON, Salt Lake City, Utah, 84124, United States
URL: https://clinicaltrials.gov/show/NCT06562907

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress