NCT06562907RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 16 Aug 2024
- Start date
- 28 Aug 2024
- Primary completion date
- Feb 2027
- Lead sponsor
- Gilead Sciences
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06562907
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 134
- From 28 Aug 2024 to the primary completion date, Feb 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qps-Mra, Llc. Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| ICON Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| ICON Early Phase Services, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.