Recruiting

Testing a new drug's effects on how the body processes fat and sugar

Plain-English translation of NCT06354088 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This research study is testing a medication called alpelisib to understand how it affects the way your body makes and stores fat. Researchers want to know whether the medication changes how your liver produces fat, especially in people who have trouble responding to insulin (a hormone that helps control blood sugar). You would receive either the real medication or a placebo (dummy pill) during two separate hospital stays.

Many people with prediabetes and fatty liver disease have trouble responding to insulin, which may lead to excessive fat buildup in the liver. Scientists don't fully understand why this happens, and this study aims to unlock that mystery so doctors can better treat these conditions.

Do you qualify?

You likely qualify if…

you are 18 to 70 years old
you speak English or Spanish fluently
you are either at a healthy weight (BMI 18–25) with normal blood sugar control, or you are overweight (BMI 30–45) with signs of insulin resistance or prediabetes
you have not been diagnosed with diabetes or gestational diabetes in the past 5 years
you are willing to stay in a hospital research unit overnight for two separate visits

You likely don't qualify if…

you are pregnant, breastfeeding, or planning to become pregnant
you have been diagnosed with diabetes or have a fasting blood sugar of 126 mg/dL or higher
you are currently taking most diabetes medications (except metformin) or certain cholesterol medications
you have a family history of familial high cholesterol or abnormal blood lipids
you have liver function tests that are severely abnormal, or blood pressure and heart rate readings that fall outside a safe range

What participation looks like

You would be admitted to a hospital research unit twice, with 2 to 8 weeks between visits. During each overnight stay, you would take either the study medication or a placebo in the evening, then receive special glucose solutions through an IV to help researchers measure how your body makes and processes fat. Blood samples would be drawn at set times, and the next day you would eat standardized meals while researchers continue monitoring your metabolism. The whole process takes about a day and a half per visit.

AI-generated summary from trial data · Jun 6, 2026 · Not medical advice

Testing a new drug's effects on how the body processes fat and sugar

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)