RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of GS-4571 and how the body handles it after one or more doses taken by mouth. It includes healthy adults, adults with obesity but no diabetes, and adults with type 2 diabetes who do not have obesity. It also tests how food, and possibly the heartburn drug omeprazole, affect how the body handles GS-4571.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 18–55 for Parts A, B, and C, or 18–65 for Part D.
  • Never used a GLP-1 receptor agonist, a type of diabetes or weight-loss drug, or last used one at least 6 months before screening.
  • Parts A and B: Healthy, with no major medical history and a BMI from 19 to less than 30. BMI is a measure of weight compared with height.
  • Parts A and B: Found to be in good general health at a study exam within 28 days before the first dose.
  • Part C: Have obesity, a BMI from 30 to less than 45, and weigh more than 50 kilograms (about 110 pounds).
  • Part C: Do not have diabetes and have an HbA1c below 6.5%. HbA1c measures average blood sugar.
  • Part C: Report less than a 5% change in body weight during the 90 days before screening.
  • Part D: Have type 2 diabetes, an HbA1c from 7.0% to 10.5%, and a BMI from 19 to less than 30. Diabetes treatment must be diet, exercise, metformin alone, or a combination of these.

Who can't join

  • A serious or active physical or mental illness, including depression, that the study doctor believes could affect treatment, testing, or following study rules. This includes past or current inflammation of the pancreas and other major illnesses.
  • Current symptoms of diabetes-related eye damage, or an eye exam showing this damage within the past year.
  • Serious problems with blood minerals, such as potassium, calcium, or magnesium, or a condition that could cause these problems, such as an eating disorder.
  • A history of fainting, a racing or pounding heartbeat, or unexplained dizziness.
  • Current or past major heart disease, problems with the heart's electrical signals, or a history of an implanted pacemaker or defibrillator.
  • Use of GLP-1 drugs, steroids that affect the whole body, drugs that weaken the immune system, or chemotherapy within 6 months before screening, or planned use during the study.
  • Previously stopped a GLP-1 drug because of severe side effects, such as nausea, constipation, diarrhea, or vomiting.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

FL

TX

UT