GS-4571 for Weight Management in Obese and Diabetic Adults

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

Recruiting Phase 1 Interventional Study
Weight Management
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
134 (estimated)
Sponsor
Gilead Sciences · Industry
Who this trial is looking for

This trial is looking for healthy adults, non-diabetic obese adults, and non-obese adults with type 2 diabetes to test a new drug called GS-4571. Participants will take the drug in different doses and be monitored for safety and effects on weight management.

Are You a Good Fit for This Trial?
Must not be taking GLP-1RAsSystemic steroidsImmunosuppressantsChemotherapy
Rules you out Diabetic retinopathyPancreatitisActive infectionSignificant cardiac disease

You may be able to join if

  • I am a healthy adult with a body mass index (BMI) of 19 to 30.
  • I am a non-diabetic obese adult with a BMI of 30 to 45.
  • I weigh more than 50 kg.
  • I have type 2 diabetes and my HbA1c is between 7.0% and 10.5%.
  • I have been stable in my weight for 90 days.
  • I have not used GLP-1RAs for the last 6 months.

You may not be able to join if

  • I have a serious medical or psychiatric illness.
  • I currently have symptoms of diabetic retinopathy.
  • I have significant electrolyte disturbances.
  • I have a history of significant heart disease.
  • I have had a syncopal episode or unexplained dizziness.
  • I have implanted devices like a defibrillator or pacemaker.
  • I stopped taking GLP-1RAs due to severe side effects.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 dose…
Trial Locations
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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 …
Contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

CONTACT