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.
Age 18 through 55 years, for Parts A, B, and C, and 18 through 65 years, for Part D.
Individuals must be glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve OR last dose was at least 6 months prior to screening.
Part A (SAD) and Part B (Food/PPI Effect): eligible individuals in Cohorts 1-4, (optional cohort 5) and 6 will include healthy individuals with BMI of ≥ 19 and < 30 kg/m², and no significant medical history.
Part C (MAD in nondiabetic obese individuals): Eligible individuals in Cohorts 7-9 and (optional cohort 10) will be individuals with obesity with BMI ≥ 30 kg/m² and < 45 kg/m² with a total body weight > 50 kg, and nondiabetic (HbA1c < 6.5%). Eligible individuals will also be individuals with stable body weight (< 5% change) for 90 days prior to screening visit based on individual report.
Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol. This would include acute pancreatitis, or history of pancreatitis, acute gallbladder disease, and renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes [with the exception of T2DM for individuals included in Part D only]), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
Current symptoms of diabetic retinopathy or examination indicating diabetic retinopathy within one year of screening.
Any electrolyte disturbances identified at screening considered to be clinically significant in the opinion of the investigator (eg, hypokalemia, hypocalcemia, or hypomagnesemia).
Any condition that could lead to electrolyte disturbances (eg, eating disorder) in the opinion of the investigator.
Parallel
GS-4571
DrugAdministered orally
Placebo
DrugAdministered orally
Omeprazole
DrugAdministered orally
Single-Dose PK Parameter AUCinf of GS-4571
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
Single-Dose PK Parameter Cmax of GS-4571
Cmax is defined as the maximum observed concentration of drug in plasma.
Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571
AUCtau is defined as area under the concentration versus time curve over the dosing interval.
Multiple-Dose Plasma PK Parameter: Cmax of GS-4571
Cmax is defined as the maximum observed concentration of drug in plasma.
Percentage Change From Baseline (CFB) in Body Weight in Nondiabetic Obese Participants
Click on the lead sponsor to view all of their trials.
