RecruitingPhase 1NCT06562907

Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)

A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Oral Doses of GS-4571 in Healthy Participants, Multiple Ascending Oral Doses of GS-4571 in Nondiabetic Obese Participants and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM), and to Evaluate the Effect of Food and an Acid-Reducing Agent on Pharmacokinetics of GS-4571

Sponsor

Gilead Sciences

Enrollment

134 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

Weight Management

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests GS-4571, a new investigational drug that may mimic the effects of GLP-1 receptor agonists (like semaglutide or liraglutide), in three groups: healthy volunteers, obese people without diabetes, and lean people with Type 2 diabetes — to evaluate its safety and how it behaves in the body. **You may be eligible if...** - You have never used a GLP-1 receptor agonist drug, or your last dose was at least 6 months ago - For the healthy or obese group: you are in generally good health with no significant medical history - For the diabetes group: you have Type 2 diabetes with HbA1c between 7% and 10.5%, managed by diet, exercise, or metformin only **You may NOT be eligible if...** - You have a history of pancreatitis or active gallbladder disease - You stopped a GLP-1 drug previously because of severe nausea, diarrhea, or vomiting - You have significant heart disease, a pacemaker, or a history of fainting or unexplained dizziness - You have had a GLP-1 drug, steroids, or immunosuppressants within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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