Alpelisib Challenge Test (ACT)

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 — DRUG
  All 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_TEST
  All 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_TEST
  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.

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 2, 2026

Status verified

Sep 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) group
  Healthy 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 group
  Volunteers with body mass index of 25.0-29.9 kg/m2, hemoglobin A1c \< 6.5%, and fasting plasma glucose \< 126 mg/dL
• Experimental: Obesity group
  Volunteers 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, PhD
  2123052663
  [email protected]
• Ishwari Nagnur
  2123059336
  [email protected]

Locations (1)

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