Study Details

OVERVIEW

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

PROTOCOL 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 effectiveness of a representative gastric acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571. To evaluate the effectiveness of concomitant food intake on the PK of GS-4571. To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.

Participation Requirements

Age

18 Years - 55 Years

Sex

ALL

Healthy Volunteers

true

Medical Condition

Weight Management

Gender

N/A

Date

August 2024 - July 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

GS-4571, Placebo, Omeprazole

Eligibility Information

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 1-6 will include healthy individuals with BMI of ≥ 19 and < 30 kg/m2, 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 7-10 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.
Part D (multiple doses in nonobese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and < 30 kg/m2 and treated with diet and/or exercise, and/or metformin monotherapy.

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 immuneor 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.

Locations

Locations (2)

ICON Early Phase Services, LLC

San Antonio, Texas, United States, 78209

ICON

Salt Lake City, Utah, United States, 84124

Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)