Insulin Resistance study: Alpelisib
Official title Alpelisib Challenge Test (ACT)
ClinicalTrials.gov ID: NCT07778524
What this study is testing
What is Alpelisib 300 mg?
An investigational oral medicine being studied for insulin resistance. It is designed to inhibit the PI3K pathway, which interferes with insulin signaling in the body.
Also referred to as Piqray.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether alpelisib can be used as an easier method to measure how much insulin a person can produce, compared to the current gold‑standard hyperglycemic clamp.
- Who it's for
- Adults who have insulin resistance, type 2 diabetes, obesity/overweight, or are otherwise healthy.
- What's involved
- Participants will undergo a hyperglycemic clamp, eat three standard meals, take one dose of alpelisib at night, and the next morning complete a mixed‑meal tolerance test with periodic blood draws.
- Time commitment
- The study involves two consecutive overnight visits (about 24 hours) with several tests and blood draws.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Adults aged 18-70 years
- Able to understand wrifen and spoken English and/or Spanish
- Body mass index of 18-45 kg/m2 (or 18-42 kg/m2 for those of Asian ancestry)
- For Lean group: BMI 18.0-24.9 kg/m2 (or 18.0-22.9 kg/m2 for those of Asian ancestry)
- For Overweight group: BMI 25.0-29.9 kg/m2 (or 23.0-27.4 kg/m2 for those of Asian ancestry)
You likely can't join if
- Inability to provide informed consent in English or Spanish
- Unwillingness to fast (except water) for up to 18 hours
- Unwillingness not to get out of bed and to use bedpan/urinal to void for up to 15 hours
- Documented weight change of ≥ 5.0% of baseline within the previous 3 months
- Abnormal blood pressure
- Systolic blood pressure \ 160 mm Hg, and/or
See the full eligibility criteria
- Adults aged 18-70 years
- Able to understand wrifen and spoken English and/or Spanish
- Body mass index of 18-45 kg/m2 (or 18-42 kg/m2 for those of Asian ancestry)
- For Lean group: BMI 18.0-24.9 kg/m2 (or 18.0-22.9 kg/m2 for those of Asian ancestry)
- For Overweight group: BMI 25.0-29.9 kg/m2 (or 23.0-27.4 kg/m2 for those of Asian ancestry)
- For Obesity group: BMI 30.0-45.0 kg/m2 (or 27.5-42 kg/m2 for those of Asian ancestry)
- Inability to provide informed consent in English or Spanish
- Unwillingness to fast (except water) for up to 18 hours
- Unwillingness not to get out of bed and to use bedpan/urinal to void for up to 15 hours
- Documented weight change of ≥ 5.0% of baseline within the previous 3 months
- Abnormal blood pressure
- Systolic blood pressure \ 160 mm Hg, and/or
- Diastolic blood pressure \ 100 mm Hg
- Abnormal resting heart rate \< 55 bpm or ≥ 110 bpm
- Sinus tachycardia that has been extensively worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion
- Sinus bradycardia between heart rates of 45 and 54 bpm may be permitted at the PI's discretion if in a clinically appropriate setting (e.g., toned athlete, taking beta blockers)
- Abnormal (i.e., non-regular) heart rhythm detected on physical exam
- Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant
- Liver function abnormalities (either of the following)
- Transaminases (AST or ALT) \> 3.0 x the upper limit of normal
- Total bilirubin \> 1.25 x the upper limit of normal
- Hemoglobin A1c ≥ 6.5%, and/or
- Fasting plasma glucose ≥ 126 mg dL-1
- Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential
- Women currently pregnant
- Women currently breastfeeding
- Hemoglobin A1c ≥ 6.5%, or rapid rise in documented HbA1c values causing clinical concern for evolving insulin deficiency
- Plasma glucose ≥ 126 mg/dL after 8-h fast
- Plasma glucose of ≥ 200 mg/dL at 2 h after ingestion of a 75-g glucose load
- Random plasma glucose ≥ 200 mg/dL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state
- History of gestational diabetes mellitus within the previous 5 years
- Use of most antidiabetic medications within the 90 days prior to screening
- Exceptions: thiazolidinediones, sulfonylureas, meglitinides, DPP4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, amylin mimetics, acarbose, insulin
- Metformin is acceptable provided that recruits meet all of the inclusion criteria at screening
- Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)
- Cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)
- Atherosclerotic cardiovascular disease
- Stable or unstable angina
- Myocardial infarction
- Ischaemic or hemorrhagic stroke
- Peripheral arterial disease (claudication)
- Use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor)
- History of percutaneous coronary intervention
- Congestive heart failure (NYHA Class ≥ 2)
- Severe valvular heart disease (e.g., aortic stenosis)
- Pulmonary hypertension
- Advanced liver fibrosis, as determined by non-invasive testing
- Cirrhosis of any etiology
- Autoimmune hepatitis or other rheumatologic disorder affecting the liver
- Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)
- Chronic liver infection (e.g., viral hepatitis, parasitic infestation)
- Hepatocellular carcinoma
- Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)
- Are or have been decompensated within 1 year of screening, and/or
- Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain/metabolic dysfunction (e.g., clozapine, olanzapine)
- Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation
- Bleeding disorders, including due to anticoagulation, or significant anemia (see above)
- Non-melanoma skin cancer
- Differentiated thyroid cancer (AJCC Stage I only)
- Clinical concern for increased risk of volume overload, including due to medications and/or heart/liver/kidney problems, as listed above
- Use of drugs prescribed for indications other than the exclusionary diagnoses/purposes listed above (e.g., ACEi/ARB used for uncomplicated hypertension rather than for congestive heart failure, etc.)
- Note, as above, that antidiabetic drugs except metformin within 30 d of screening are excluded
- Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted
- Roux-en-Y gastric bypass
- Biliopancreatic diversion
- Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months
- Clinical concern for alcohol overuse based on chart review and/or by recruit's report of more than 14 standard drinks per week for males or more than 7 standard drinks per week for females
- Regular tobacco use (smoking more than 1 cigarette per week) or regular nicotine vaping (daily)
- Clinical concern for use of illicit drugs other than marijuana or lawfully prescribed medications based on recruit's report, chart review, and point-of-care urine drug test at screening
- History of or ongoing febrile illness within 14 days of screening
- Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and/or interfere with the analysis of study data.
- Known allergy/hypersensitivity to any component of the medicinal product formulations (including soy, cow dairy, or gluten), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically...
- Concurrent enrollment in another clinical study of any investigational drug/biologic therapy within 5 half-lives of an investigational agent or biologic.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.