NCT07778524|RecruitingPhase 1FDA Drug
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Sponsor study identifier
Secondary identifiers
NIH
interventional
15
1 country
1
Study Start
September 2, 2026
Actual (reported)Primary Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this study is to test a potentially easier method for measuring how much insulin a person is capable of producing than the current gold-standard method, the "hyperglycemic clamp." Participants will come in for a two-day (overnight) visit in which they will first undergo a "hyperglycemic clamp," in which they receive an intravenous (into the vein) infusion of glucose (sugar) in order to measure the maximum amount of insulin their body produces in response. They will then consume a series of three standardized meals throughout the rest of the day. At 23:00, they will take a single dose of alpelisib, a drug that interferes within insulin's actions in the body. Then, the following morning, they will undergo a "Mixed Meal Tolerance Test" in which they consume a standardized liquid nutritional beverage and have blood drawn periodically before and during the test.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2026
Actual (reported)August 21, 2026
Actual (reported)September 2, 2026
Actual (reported)August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Correlation coefficient between clamp and ACT/MMTT
Determination of utility of Alpelisib Challenge Test as measure of pancreatic beta-cell reserve based on correlation of insulin/C-peptide levels and/or insulin secretion rates during MMTT portion of ACT versus gold-standard hyperglycemic clamp
Up to 17 hours after dosing alpelisib
Serum insulin level
After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Serum C-peptide level
After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Healthy volunteers with body mass index of 18.0-24.9 kg/m2, hemoglobin A1c \< 6.5%, and fasting plasma glucose \< 126 mg/dL
Volunteers with body mass index of 25.0-29.9 kg/m2, hemoglobin A1c \< 6.5%, and fasting plasma glucose \< 126 mg/dL
All participants will ingest one dose of alpelisib 300 mg (2 x 150-mg tablets) at 23:00 on Study Day 1
Columbia University Irving Medical Center
New York, New York, 10032, United States
Joshua R Cook, MD, PhD
Columbia University
First Submitted
August 18, 2026
First Posted
August 21, 2026
Study Start
September 2, 2026
Actual (reported)Primary Completion
August 31, 2028
EstimatedGraded Insulin Suppression Test P&F
Insulin secretion rate (ISR)
After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Insulin clearance rate (ICR)
After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Plasma glucose level
After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Plasma alpelisib level
10 hours after alpelisib dose
Volunteers with body mass index of 30.0-45.0 kg/m2, hemoglobin A1c \< 6.5%, and fasting plasma glucose \< 126 mg/dL
All participants will ingest standardized mixed meals of Nestlé BOOST Plus on the morning of Study Day 2 after taking alpelisib the previous evening
All participants will undergo a two-hour hyperglycemic clamp procedure to measure pancreatic insulin reserve on the morning of Study Day 1, prior to taking alpelisib. This procedure involves an infusion of dextrose 20% solution.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 3, 2026
Record last verified: 2026-09
Demographic information (sex, age range, BMI range) and all Primary and Secondary outcome measures
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Source: ClinicalTrials.gov.
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