Evaluating GS-4571 in Healthy and Obese Participants with Type 2 Diabetes
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
This study is testing a new drug called GS-4571 in healthy people and those with obesity or Type 2 diabetes to see how safe it is and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Gilead Sciences Industry-sponsored |
| Locations | 3 sites (Miami, Florida and 2 other locations) |
| Trial ID | NCT06562907 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety and pharmacokinetics of the drug GS-4571 in three distinct groups: healthy participants, healthy non-diabetic obese participants, and non-obese participants with Type 2 Diabetes Mellitus (T2DM). The study will involve administering single and multiple ascending doses of GS-4571, with evaluations of how food intake and an acid-reducing agent (omeprazole) affect the drug's pharmacokinetics. Participants will be monitored for safety and tolerability throughout the study. The research is designed to gather critical data that could inform future treatment strategies for weight management and diabetes.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals, nondiabetic obese individuals, and non-obese individuals with Type 2 Diabetes Mellitus who meet specific BMI and health criteria.
Not a fit: Patients who are not GLP-1RA naïve or have significant medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for weight management and Type 2 Diabetes Mellitus.
How similar studies have performed: Other studies have shown promise in evaluating pharmacokinetics and safety of similar drugs, but this specific approach with GS-4571 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Miami, Florida and 2 other locations
- Qps-Mra, Llc. — Miami, Florida, United States (Recruiting)
- ICON Early Phase Services, LLC — San Antonio, Texas, United States (Recruiting)
- Icon — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Gilead Clinical Study Information Center
- Email: GileadClinicalTrials@gilead.com
- Phone: 1-833-445-3230 (GILEAD-0)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.