Alpelisib Challenge Test (ACT)
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT07778524
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Healthy Adult Participants
- Insulin Resistance
- Obesity & Overweight
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Accepted
Interventions
- Alpelisib 300 mg — DRUGAll participants will ingest one dose of alpelisib 300 mg (2 x 150-mg tablets) at 23:00 on Study Day 1
- Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib — DIAGNOSTIC_TESTAll participants will ingest standardized mixed meals of Nestlé BOOST Plus on the morning of Study Day 2 after taking alpelisib the previous evening
- Hyperglycemic clamp — DIAGNOSTIC_TESTAll 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.
Study Details
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.
Key Dates
- First listed
- Aug 21, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Lean (healthy control) groupHealthy volunteers with body mass index of 18.0-24.9 kg/m2, hemoglobin A1c \< 6.5%, and fasting plasma glucose \< 126 mg/dL
- Experimental: Overweight groupVolunteers with body mass index of 25.0-29.9 kg/m2, hemoglobin A1c \< 6.5%, and fasting plasma glucose \< 126 mg/dL
- Experimental: Obesity groupVolunteers with body mass index of 30.0-45.0 kg/m2, hemoglobin A1c \< 6.5%, and fasting plasma glucose \< 126 mg/dL
Primary Outcome Measure
Correlation coefficient between clamp and ACT/MMTT [ Time Frame: Up to 17 hours after dosing alpelisib ]
Central Contacts
- Joshua R Cook, MD, PhD2123052663
- Ishwari Nagnur2123059336
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | Joshua R Cook, MD, PhD (PRINCIPAL_INVESTIGATOR) Blandine Laferrère, MD, PhD (SUB_INVESTIGATOR) Henry N Ginsberg, MD (SUB_INVESTIGATOR) |
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