Recruiting
Phase 1

GS-4571

Sponsor:

Gilead Sciences

Code:

NCT06562907

Conditions

Weight Management

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

GS-4571

Placebo

Omeprazole

Study Details

Brief 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.

Conditions

Weight Management

Study ID

NCT06562907

Start date

Aug 28, 2024

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Key Inclusion Criteria:

  • 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.

Individuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A Single-ascending Dose (SAD) in Healthy Participants

Participants will be randomized into 4 + (optional) 1 dose escalating cohorts and will receive GS-4571 or placebo to match (PTM) GS-4571 on Day 1, to determine the maximum tolerated dose:

  • Cohort 1: Dose 1 GS-4571, administered orally as a single dose, in a fasting state.
  • Cohort 2: Dose 2 GS-4571, administered orally as a single dose, in a fasting state.
  • Cohort 3: Dose 3 GS-4571, administered orally as a single dose, in a fasting state.
  • Cohort 4: Dose 4 GS-4571, administered orally as a single dose, in a fasting state.
  • Cohort 5 (optional): Dose 5 GS-4571, administered orally as a single dose, in a fasting state.

experimental: Part B Food/PPI Effect in Healthy Participants

Participants will be randomized into 2 sequence groups in Cohort 6 and will receive the highest dose found to be safe and well tolerated in Part A of GS-4571 and omeprazole. The two sequential groups will receive the following treatments:

  • Treatment A: Up to the highest single dose of GS-4571 evaluated in Part A, fasting.
  • Treatment B: Up to the highest single dose of GS-4571 evaluated in Part A, nonfasting (high-fat/high-calorie meal).
  • Treatment C (optional): Omeprazole, once-daily (QD) for 5 days, fasting.
  • Treatment D (optional): Omeprazole followed by up to the highest single dose of GS-4571 evaluated in Part A, 2 hours later, fasting.

experimental: Part C Multiple-ascending Dose (MAD) in Nondiabetic Obese Participants

Participants randomized in Cohorts 7-9 will be randomized to receive up to 4 escalating doses of GS-4571 or PTM QD for 12 weeks, as follows:

  • Cohort 7: Up to dose determined from Part A of GS-4571 or PTM in obese participants, QD, in a non-fasting state
  • Cohort 8: Up to 3-fold the Cohort 7 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state
  • Cohort 9: Up to 2-fold the Cohort 8 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state
  • Cohort 10 is optional and will receive GS-4571 or PTM QD for 12 weeks in case it is opened for enrollment as follows:

  • Up to 2-fold the Cohort 9 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state.

experimental: Part D Multiple Dose in Nonobese Participants With T2DM

Participants randomized in Cohort 11 will receive up to the highest dose of GS-4571 or PTM in T2DM, QD, in a non-fasting state for 12 weeks.

Interventions

GS-4571

Administered orally

Placebo

Administered orally

Omeprazole

Administered orally

Primary outcome measure

  • Single-Dose PK Parameter AUCinf of GS-4571 [ Time Frame: Up to 96 hours postdose ]
  • Single-Dose PK Parameter Cmax of GS-4571 [ Time Frame: Up to 96 hours postdose ]
  • Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571 [ Time Frame: Up to 96 hours postdose ]
  • Multiple-Dose Plasma PK Parameter: Cmax of GS-4571 [ Time Frame: Up to 96 hours postdose ]
  • Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths [ Time Frame: Day 1 up to 95 days ]
  • Percentage of Participants of Treatment-Emergent Laboratory Abnormalities [ Time Frame: Day 1 up to 95 days ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Qps-Mra, Llc.

Recruiting

Miami, Florida, United States, 33143

ICON Early Phase Services, LLC

Recruiting

San Antonio, Texas, United States, 78232

ICON

Recruiting

Salt Lake City, Utah, United States, 84124

More Information

Sponsor

Gilead Sciences

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-06-22.