Actively Recruiting
Study of GS-4571 Safety and Pharmacokinetics in Healthy, Obese, and Type 2 Diabetes Mellitus Participants with Food and Acid-Reducing Agent Effects
Led by Gilead Sciences · Updated on 2026-05-27
134
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the drug GS-4571 to understand its safety and how it behaves in the body in three groups: healthy people, healthy obese people without diabetes, and non-obese people with Type 2 Diabetes Mellitus (T2DM). This Phase 1 clinical trial aims to find the best dose by testing single and multiple doses, and to see how food and an acid-reducing drug (omeprazole) affect GS-4571 in the body. Participants will be randomly assigned to different groups receiving escalating doses of GS-4571 or placebo in fasting and non-fasting conditions. Some groups will also receive omeprazole to evaluate its effect on the drug. Treatment periods range from a single dose to 12 weeks of once-daily dosing, depending on the cohort and participant group, including healthy, obese, and T2DM participants. During the study, participants will undergo blood tests to measure GS-4571 levels and monitor safety from the first dose up to 95 days. Researchers will track side effects, laboratory changes, and body weight changes in obese participants. The study includes regular visits and evaluations to assess drug effects and tolerability, with total participation time varying by group and dose schedule.
CONDITIONS
Brief 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 GLP-1 receptor agonist (GLP-1RA) naïve or have not taken it for at least 6 months before screening.
- Healthy participants in Parts A and B must have a BMI between 19 and less than 30 kg/m² and no significant medical history.
- Nondiabetic obese participants in Part C must have a BMI between 30 and less than 45 kg/m², weigh over 50 kg, and have stable weight for 90 days before screening.
- Non-obese participants with T2DM in Part D must have HbA1c between 7.0% and 10.5%, BMI between 19 and less than 30 kg/m², and be treated with diet, exercise, or metformin only.
- Participants must be in good general health as determined by the investigator within 28 days prior to dosing.
You will not qualify if you...
- Serious or active medical or psychiatric illness that could interfere with treatment or study compliance, including acute or history of pancreatitis, gallbladder disease, or significant cardiac, renal, hepatic, pulmonary, endocrine, central nervous, gastrointestinal, vascular, metabolic, immunodeficiency, infection, or malignancy conditions.
- Current symptoms or examination signs of diabetic retinopathy within one year prior to screening.
- Clinically significant electrolyte disturbances or conditions that could cause these, such as eating disorders.
- History of syncope, palpitations, or unexplained dizziness.
- Significant cardiac disease or conduction abnormalities, including history of implanted defibrillator or pacemaker.
- Use of GLP-1RAs, systemic steroids, immunosuppressants, or chemotherapy agents within 6 months before screening or expected during the study.
- Previous discontinuation of GLP-1RAs due to severe side effects like nausea, constipation, diarrhea, or vomiting.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 12 weeks
Participants receive GS-4571 or placebo orally in various dosing regimens to evaluate safety and pharmacokinetics. This includes single doses, multiple ascending doses, and dosing with food or omeprazole effects.
Multiple visits during dosing period as per cohort assignment
Duration - Up to 3 weeks after treatment ends
Participants are monitored for safety and treatment-emergent adverse events after the last dose of study drug.
Approximately 1 to 2 post-treatment visits
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, 78232
Actively Recruiting
3
ICON
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
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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