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Investigational Drug

GS-4571 for Type 2 Diabetes

Phase 1

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part A (SAD) and Part B (Food/PPI Effect): eligible individuals in Cohorts 1-6 will include healthy individuals with BMI of ≥ 19 and < 30 kg/m2, and no significant medical history

Part C (MAD in nondiabetic obese individuals): eligible individuals in Cohorts 7-10 will be individuals with obesity with BMI ≥ 30 kg/m2 and < 45 kg/m2 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

Must not have

History of syncope, palpitations, or unexplained dizziness

Active, or history of, significant cardiac disease or conduction abnormality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 96 hours postdose

Summary

This trial aims to study the safety and effectiveness of a new drug, GS-4571, in three different groups of people: healthy individuals, healthy obese individuals, and non-obese individuals with Type

Who is the study for?

This trial is for healthy adults, non-diabetic obese individuals, and non-obese people with Type 2 Diabetes. Participants should have a stable body weight and meet specific BMI criteria: healthy (19-30 kg/m2), obese (30-45 kg/m2), diabetic (19-30 kg/m2). Diabetics can only be on diet/exercise or metformin, and must not have used GLP-1RA drugs recently.

What is being tested?

The study tests GS-4571's safety and how the body processes it after different doses. It also looks at how omeprazole (a stomach acid reducer) or eating food affects GS-4571 in the system. The drug is given orally to three groups: healthy individuals, obese without diabetes, and diabetics without obesity.

What are the potential side effects?

Possible side effects of GS-4571 are not detailed here but typically include reactions related to digestion due to its oral administration. Omeprazole may cause headaches, nausea, vomiting, gas; however individual experiences vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy with a BMI between 19 and 30, and no significant medical history.

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I am obese with a BMI between 30 and 45, weigh more than 50 kg, am not diabetic, and my weight has been stable for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have experienced fainting, heart palpitations, or unexplained dizziness.

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I have, or had, a serious heart condition.

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I have symptoms or a diagnosis of diabetic retinopathy in the last year.

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I have not used GLP-1RAs, steroids, immunosuppressants, or chemotherapy in the last 6 months.

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I stopped taking GLP-1RAs due to severe side effects like nausea or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 96 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 96 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571

Multiple-Dose Plasma PK Parameter: Cmax of GS-4571

Single-Dose PK Parameter AUCinf of GS-4571

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D Multiple Dose in Nonobese Participants With T2DMExperimental Treatment2 Interventions

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.

Group II: Part C Multiple-ascending Dose (MAD) in Nondiabetic Obese ParticipantsExperimental Treatment2 Interventions

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.

Group III: Part B Food/PPI Effect in Healthy ParticipantsExperimental Treatment2 Interventions

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: Omeprazole, once-daily (QD) for 5 days, fasting. * Treatment D: Omeprazole followed by up to the highest single dose of GS-4571 evaluated in Part A, 2 hours later, fasting.

Group IV: Part A Single-ascending Dose (SAD) in Healthy ParticipantsExperimental Treatment2 Interventions

Participants will be randomized into 5 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: Dose 5 GS-4571, administered orally as a single dose, in a fasting state.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omeprazole

2006

Completed Phase 4

~940

Placebo

1995

Completed Phase 3

~2670