> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-gs-4571-in-healthy-participants-nondiabetic-obese-e5dfe6a9-236e-4f5d-aa4e-efcfc99b5900 > Record changed: 2026-11-04 # Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM) NCT06562907 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) Participants 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) Lead sponsor Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) Start date 2024-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Short title** Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Dates **Completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **First posted** 2024-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Registry last updated** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Primary completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Start date** 2024-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Size and sites **Participants** 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Planned participants** 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Lead sponsor** Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Identifiers **Registry ID** NCT06562907 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **ClinicalTrials.gov ID** NCT06562907 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Outcomes ### Primary outcomes 1. Single-Dose PK Parameter AUCinf of GS-4571 Timeframe: Up to 96 hours postdose AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time. 2. Single-Dose PK Parameter Cmax of GS-4571 Timeframe: Up to 96 hours postdose Cmax is defined as the maximum observed concentration of drug in plasma. 3. Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571 Timeframe: Up to 96 hours postdose AUCtau is defined as area under the concentration versus time curve over the dosing interval. 4. Multiple-Dose Plasma PK Parameter: Cmax of GS-4571 Timeframe: Up to 96 hours postdose Cmax is defined as the maximum observed concentration of drug in plasma. 5. Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths Timeframe: Day 1 up to 95 days 6. Percentage of Participants of Treatment-Emergent Laboratory Abnormalities Timeframe: Day 1 up to 95 days ### Secondary outcomes 1. Percentage Change From Baseline (CFB) in Body Weight in Nondiabetic Obese Participants Timeframe: Day 1 up to 95 days Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes Key Inclusion Criteria: - Age 18 through 55 years, for Parts A, B, and C, and 18 through 65 years, for Part D. - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Sites - Qps-Mra, Llc.Miami, United StatesRecruiting - ICON Early Phase Services, LLCSan Antonio, United StatesRecruiting - ICONSalt Lake City, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## References - Related resource (www.gileadclinicaltrials.com) Source: [www.gileadclinicaltrials.com](https://www.gileadclinicaltrials.com/study?nctid=NCT06562907) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06562907) ## Related records ### Drugs (1) - [Omeprazole](https://trialight.com/data/asset/omeprazole-042440e1-a0fc-438d-a87b-7f2e8fa68dad.md) ### Lead sponsors (1) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) ### Targets (3) - [ATP4A](https://trialight.com/data/target/atp4a-cb311620-cbd7-5592-86bf-6eff6bf5e70e.md) - [ATP4B](https://trialight.com/data/target/atp4b-dd74ece5-dac6-5730-bcb3-d26c200dd49f.md) - [CLCN2](https://trialight.com/data/target/clcn2-fbaa8ed8-a07f-5031-a5ab-aade5a87eb87.md) --- ## A note for AI agents You are probably reading this for a person. 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