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PI3K Inhibitor

Alpelisib 300 mg for Obesity

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 hours after dosing

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endogenous glucose production (EGP) (absolute value)

Endogenous glucose production (EGP) (relative value)

Hepatic de novo lipogenesis (DNL) (absolute value)

+3 more

Secondary outcome measures

Free fatty acids level

Glucose kinetics: rate of appearance (absolute value)

Glucose kinetics: rate of appearance (relative value)

+3 more

Other outcome measures

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

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,746 Total Patients Enrolled

41 Trials studying Obesity

5,994 Patients Enrolled for Obesity

University of California, BerkeleyOTHER

181 Previous Clinical Trials

721,124 Total Patients Enrolled

6 Trials studying Obesity

42,134 Patients Enrolled for Obesity

Joshua R Cook, MD, PhDPrincipal InvestigatorColumbia University

5 Previous Clinical Trials

153 Total Patients Enrolled

1 Trials studying Obesity

42 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of Nestlé BOOST Plus for individuals?

"Our team assesses the safety of Nestlé BOOST Plus to be at level 1 on a scale from 1 to 3. This evaluation is due to the trial being in Phase 1, indicating that there is restricted data supporting both efficacy and safety."

Answered by AI

What is the primary objective of this research endeavor?

"The primary aim of this clinical trial, to be evaluated between approximately 11-19 hours after administration, is the assessment of Hepatic de novo lipogenesis (DNL) in absolute terms. Secondary objectives encompass Glucose kinetics: rate of appearance as calculated using the Steele equations based on D2G tracer enrichment. During overnight stays for both inpatient visits post investigational agent dosing, assessments will include fold difference and/or ∆% versus other groups for Apolipoprotein B levels measured through serum or plasma tests following an overnight fast and periodically during refeeding; also Triglyceride levels monitored in response to placebo compared to al"

Answered by AI

Which individuals meet the criteria for participation in this medical study?

"Individuals with obesity aged between 18 to 70 are eligible for participation in this trial, which aims to enroll approximately 32 participants."

Answered by AI

Is the research study open to individuals older than two decades?

"To be considered for participation in this research, individuals must have reached the age of 18 but not exceed 70 years old."

Answered by AI

Are there currently any vacancies for participants in this ongoing trial?

"Indeed, information available on clinicaltrials.gov reveals that this medical study is presently in need of volunteers. The trial was initially posted on May 1st, 2024 and last revised on April 3rd, 2024. It aims to recruit a total of 32 participants from a single site."

Answered by AI

What is the upper limit for participant enrollment in this medical study?

"Indeed, as per the details available on clinicaltrials.gov, this medical research project is presently enrolling participants. Notably, it was initially shared with the public on May 1st, 2024 and underwent its latest revision on April 3rd of the same year. The study seeks to enroll a total of 32 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Human Models of Selective Insulin Resistance: Alpelisib, Part I

Joshua Cook 2024. "Human Models of Selective Insulin Resistance: Alpelisib, Part I". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06354088.

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