← Back to Search

PI3K Inhibitor

Alpelisib for Insulin Resistance

Phase 1
Recruiting
Led By Joshua R Cook, MD, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 hours after dosing

Summary

This trial aims to study how the hormone insulin functions in healthy adults and those at risk for type 2 diabetes. Researchers will use a drug called alpelisib to see if the liver continues to

Who is the study for?
This trial is for healthy adults and those at risk for type 2 diabetes, specifically with conditions like liver disease, obesity, non-alcoholic fatty liver disease (NAFLD), prediabetes, and insulin resistance. Participants should be willing to stay overnight in the hospital twice and follow study procedures.
What is being tested?
Researchers are testing alpelisib's effects on how the body responds to insulin by comparing it with a placebo. The study involves taking single doses of both substances during separate hospital stays and measuring glucose and fat production using special tracer molecules.
What are the potential side effects?
Possible side effects from alpelisib may include nausea, increased blood sugar levels, rash or itching skin, fatigue, decreased appetite or diarrhea. Placebo typically has no active ingredients but can cause reactions based on expectations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 hours after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 hours after dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endogenous glucose production (EGP) (absolute value)
Endogenous glucose production (EGP) (relative value)
Hepatic de novo lipogenesis (DNL) (absolute value)
+3 more
Secondary study objectives
Free fatty acids level
Glucose kinetics: rate of appearance (absolute value)
Glucose kinetics: rate of appearance (relative value)
+3 more
Other study objectives
Apolipoprotein B level

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo then alpelisib (Insulin Sensitive group)Experimental Treatment5 Interventions
On Study Visit 1, participants in the Insulin Sensitive (IS) group will undergo fasting and refed measurement of de novo lipogenesis (DNL) and endogenous glucose production (EGP) following a single dose of placebo. Then, 2-8 weeks later on Study Visit 2, participants will undergo measurement of DNL and EGP after a single dose of alpelisib 300 mg.
Group II: Placebo then alpelisib (Insulin Resistant group)Experimental Treatment5 Interventions
On Study Visit 1, participants in the Insulin Resistant (IR) group will undergo fasting and refed measurement of de novo lipogenesis (DNL) and endogenous glucose production (EGP) following a single dose of placebo. Then, 2-8 weeks later on Study Visit 2, participants will undergo measurement of DNL and EGP after a single dose of alpelisib 300 mg.
Group III: Alpelisib then placebo (Insulin Sensitive group)Experimental Treatment5 Interventions
On Study Visit 1, participants in the Insulin Sensitive (IS) group will undergo fasting and refed measurement of de novo lipogenesis (DNL) and endogenous glucose production (EGP) following a single dose of alpelisib 300 mg. Then, 2-8 weeks later on Study Visit 2, participants will undergo measurement of DNL and EGP after a single dose of placebo.
Group IV: Alpelisib then placebo (Insulin Resistant group)Experimental Treatment5 Interventions
On Study Visit 1, participants in the Insulin Resistant (IR) group will undergo fasting and refed measurement of de novo lipogenesis (DNL) and endogenous glucose production (EGP) following a single dose of alpelisib 300 mg. Then, 2-8 weeks later on Study Visit 2, participants will undergo measurement of DNL and EGP after a single dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,158 Total Patients Enrolled
11 Trials studying Non-alcoholic Fatty Liver Disease
300 Patients Enrolled for Non-alcoholic Fatty Liver Disease
University of California, BerkeleyOTHER
186 Previous Clinical Trials
640,716 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
90 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Joshua R Cook, MD, PhDPrincipal InvestigatorColumbia University
8 Previous Clinical Trials
198 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
155 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~21 spots leftby May 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top