Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6737
Source ID: NCT06354088
Associated Drug: Alpelisib 300 Mg
Title: Human Models of Selective Insulin Resistance: Alpelisib, Part I
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Insulin Resistance|Prediabetic State|Overweight and Obesity|Non-Alcoholic Fatty Liver Disease
Interventions: DRUG: Alpelisib 300 mg|DRUG: Placebo|DRUG: [1-13C] sodium acetate|DRUG: [6,6-2H2] D-glucose|DIETARY_SUPPLEMENT: Nestlé BOOST Plus
Outcome Measures: Primary: Hepatic de novo lipogenesis (DNL) (absolute value), Percent incorporation of newly synthesized fatty acids into plasma or VLDL TG. During both inpatient (overnight) study visits, starting after investigational agent dose. units: %, Up to 24 hours after dosing|Hepatic de novo lipogenesis (DNL) (relative value), Percent incorporation of newly synthesized fatty acids into plasma or VLDL TG. During both inpatient (overnight) study visits, starting after investigational agent dose. unit: fold difference and/or ∆% versus other group, Up to 24 hours after dosing|Endogenous glucose production (EGP) (absolute value), Calculated from D2G tracer enrichment by the Steele equations. During both inpatient (overnight) study visits, starting after investigational agent dose. units: mg/kg/min, Up to 15 hours after dosing|Endogenous glucose production (EGP) (relative value), Calculated from D2G tracer enrichment by the Steele equations. During both inpatient (overnight) study visits, starting after investigational agent dose. units: fold difference and/or ∆% versus other group, Up to 15 hours after dosing | Secondary: Serum insulin level, Serum insulin levels in response to placebo vs alpelisib following an overnight fast and then hourly during refeeding. During Study Day 2 of both study visits, starting after investigational agent dose. units: µIU/mL, Approximately 11-19 hours after dosing|Plasma glucose level, Plasma glucose levels in response to placebo vs alpelisib following an overnight fast and then hourly during refeeding. During Study Day 2 of both study visits, starting after investigational agent dose. units: mg/dL, Approximately 11-19 hours after dosing|Triglycerides level, (Serum or plasma) triglyceride levels in response to placebo vs alpelisib following an overnight fast and then hourly during refeeding. During Study Day 2 of both study visits, starting after investigational agent dose. units: mg/dL, Approximately 11-19 hours after dosing|Free fatty acids level, (Serum or plasma) triglyceride levels in response to placebo vs alpelisib following an overnight fast and then periodically during refeeding. During Study Day 2 of both study visits, starting after investigational agent dose. units: mmol/L, Approximately 11-19 hours after dosing|Glucose kinetics: rate of appearance (absolute value), Calculated from D2G tracer enrichment by the Steele equations. During both inpatient (overnight) study visits, starting after investigational agent dose. units: mg/kg/min, Up to 15 hours after dosing|Glucose kinetics: rate of appearance (relative value), Calculated from D2G tracer enrichment by the Steele equations. During both inpatient (overnight) study visits, starting after investigational agent dose. units: fold difference and/or ∆% versus other group, Up to 15 hours after dosing|Glucose kinetics: rate of disappearance (absolute value), Calculated from D2G tracer enrichment by the Steele equations. During both inpatient (overnight) study visits, starting after investigational agent dose. units: mg/kg/min, Up to 15 hours after dosing|Glucose kinetics: rate of disappearance (relative value), Calculated from D2G tracer enrichment by the Steele equations. During both inpatient (overnight) study visits, starting after investigational agent dose. units: fold difference and/or ∆% versus other group, Up to 15 hours after dosing
Sponsor/Collaborators: Sponsor: Columbia University | Collaborators: University of California, Berkeley|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Stanford University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-24
Completion Date: 2026-12
Results First Posted:
Last Update Posted: 2025-02-13
Locations: Columbia University Irving Medical Center, New York, New York, 10032, United States
URL: https://clinicaltrials.gov/show/NCT06354088