Actively Recruiting
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
Led by Gilead Sciences · Updated on 2026-03-17
134
Participants Needed
3
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals must be naïve to glucagon-like peptide-1 receptor agonist (GLP-1RA) or have last used it at least 6 months before screening.
- Healthy participants with BMI ≥ 19 and < 30 kg/m² and no significant medical history are eligible for Part A and B cohorts.
- Nondiabetic obese participants with BMI ≥ 30 and < 45 kg/m², weight > 50 kg, and HbA1c < 6.5% with stable body weight for 90 days prior to screening are eligible for Part C cohorts.
- Non-obese participants with Type 2 Diabetes Mellitus (T2DM) with HbA1c ≥ 7.0% and ≤ 10.5%, BMI ≥ 19 and < 30 kg/m², treated with diet, exercise, and/or metformin monotherapy are eligible for Part D cohort.
- Individuals must be in good general health as determined by the investigator within 28 days before dosing.
You will not qualify if you...
- Having serious or active medical or psychiatric illnesses that could interfere with treatment or study compliance, including acute pancreatitis, gallbladder disease, renal, cardiac, hematological, hepatic, pulmonary, endocrine (except T2DM for Part D), central nervous, gastrointestinal, vascular, metabolic, immunodeficiency, active infection, or malignancy.
- Current symptoms or examination indicating diabetic retinopathy within one year of screening.
- Clinically significant electrolyte disturbances at screening (e.g., low potassium, calcium, or magnesium).
- Conditions leading to electrolyte disturbances such as eating disorders.
- History of syncope, palpitations, or unexplained dizziness.
- Active or history of significant cardiac disease or conduction abnormality.
- History of implanted defibrillator or pacemaker.
- Treatment with GLP-1RAs, systemic steroids, immunosuppressants, or chemotherapy within 6 months prior to screening or expected during the study.
- Previous discontinuation of GLP-1RAs due to severe side effects like nausea, constipation, diarrhea, or vomiting.
- Other protocol-defined inclusion or exclusion criteria may apply.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Qps-Mra, Llc.
Miami, Florida, United States, 33143
Actively Recruiting
2
ICON Early Phase Services, LLC
San Antonio, Texas, United States, 78209
Actively Recruiting
3
ICON
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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