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Study of GS-4571 for Weight Management

This study is testing a new oral drug called GS-4571 to understand how it works in the body (pharmacokinetics) and if it is safe. Researchers are also looking at how food and another drug, omeprazole, might affect GS-4571. This study includes healthy people, healthy people with obesity but not diabetes, and people with Type 2 Diabetes Mellitus (T2DM) who are not obese. To join, you must be between 18 and 55 years old and have not used certain diabetes medications (GLP-1RA) recently. The study aims to enroll 134 participants. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive either GS-4571 or a placebo (an inactive substance). It aims to enroll 134 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 96 hours after their last dose to measure drug levels in their body.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06562907

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Gilead Sciences
~134 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:GS-4571PlaceboOmeprazole

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Single-Dose PK Parameter AUCinf of GS-4571
Measured over Up to 96 hours postdose
+5 more outcomes measured

Conditions

Weight Management

Explore related trials

HealthyObesityType 2 Diabetes Mellitus

Where it's being run

3 sites across 3 states
Florida1
Texas1
Utah1

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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/m\^2, 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/m\^2 and \< 45 kg/m\^2 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.
Part D (multiple doses in non-obese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and \< 30 kg/m\^2 and treated with diet and/or exercise, and/or metformin monotherapy.

Exclusion

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.
History of syncope, palpitations, or unexplained dizziness.
Active, or history of, significant cardiac disease or conduction abnormality
History of implanted defibrillator or pacemaker.
Have been treated with the following within 6 months prior to screening or is expected to receive these agents during the study: GLP-1RAs, systemic steroids, immunosuppressant therapies, or chemotherapeutic agents (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).
Previously stopped use of GLP-1RAs secondary to severe side effects including nausea, constipation, diarrhea, or emesis.

What this trial measures

  • Single-Dose PK Parameter AUCinf of GS-4571Up to 96 hours postdose

    AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.

  • Single-Dose PK Parameter Cmax of GS-4571Up to 96 hours postdose

    Cmax is defined as the maximum observed concentration of drug in plasma.

  • Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571Up to 96 hours postdose

    AUCtau is defined as area under the concentration versus time curve over the dosing interval.

  • Multiple-Dose Plasma PK Parameter: Cmax of GS-4571Up to 96 hours postdose

    Cmax is defined as the maximum observed concentration of drug in plasma.

  • Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or DeathsDay 1 up to 95 days
  • Percentage of Participants of Treatment-Emergent Laboratory AbnormalitiesDay 1 up to 95 days