Insulin ResistancePhase 1NCT07778524
Alpelisib Challenge Test (ACT)
A Phase 1 study testing Alpelisib 300 mg, Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib and Hyperglycemic clamp in people with Insulin Resistance and Type 2 Diabetes, run by Columbia University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes, Obesity & Overweight
- What is being tested?
- Alpelisib 300 mg, Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib and Hyperglycemic clamp
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2026to 31 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 < 90 mm Hg or > 160 mm Hg, and/or
Show all 75Show fewer
- Diastolic blood pressure < 55 mm Hg or > 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
- Laboratory evidence of diabetes mellitus:
- 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
- History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):
- 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 or severe liver disease, including but not limited to:
- 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)
- Psychiatric diseases causing functional impairment that:
- 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)
- Active malignancy, or hormonally active benign neoplasm, except allowances for:
- 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 certain medications currently or within 30 days prior to screening:
- Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 30 d prior to screening, except allowances for:
- 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
- History of certain weight-loss (bariatric) surgery, including:
- 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 important allergy/hypersensitivity as judged by the investigator.
- Concurrent enrollment in another clinical study of any investigational drug/biologic therapy within 5 half-lives of an investigational agent or biologic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Joshua R. Cook, MD, PhD, 212-305-6289, jrc2175@cumc.columbia.edu
Ishwari Nagnur, 2123059336, imn2113@cumc.columbia.edu
About this study
Official title: Alpelisib Challenge Test (ACT) for Assessment of Pancreatic β-Cell Reserve, Pilot & Feasibility Study
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.
Read the detailed description
Type 2 diabetes results from a combination of insulin resistance and failure of pancreatic beta cells to produce sufficient insulin to compensate for it. Beta cell failure is therefore central to type 2 diabetes pathophysiology, and assessment of beta-cell reserve carries prognostic significance for likelihood of progression to type 2 diabetes. Beta-cell reserve may also serve as a useful clinical endpoint for the prevention or treatment of type 2 diabetes. The gold standard for measuring beta-cell reserve is the hyperglycemic clamp technique, which quantifies insulin secretion in response to hyperglycemia induced by exogenous glucose infusion. The hyperglycemic clamp, however, is technically challenging and not suitable for large-scale use, including in many research settings. As such, oral-based methods such as the oral glucose tolerance test (OGTT) and mixed-meal tolerance test (MMTT) have been developed to assess beta-cell reserve. Although these measures are useful, they come with important limitations. The investigators therefore wish to improve upon these oral methods by imposing a near-maximal beta-cell challenge during MMTT. The investigators have designed the Alpelisib Challenge Test (ACT) for this purpose, as alpelisib induces temporary, high-grade insulin resistance that will then allow a more accurate assessment of insulin-secretory capacity during MMTT. Study volunteers will be admitted to the inpatient clinical research unit for one overnight, 30-hour stay. On the morning of Study Day 1, they will undergo the gold-standard hyperglycemic clamp technique to assess beta-cell reserve. Then, at bedtime, they will take a single dose of alpelisib 300 mg followed by measurement of insulin secretion during MMTT on the morning of Study Day 2. This study can therefore determine the potential validity of the ACT by determining correlation coefficients with beta-cell reserve as measured during the hyperglycemic clamp.
- Being tested
- Alpelisib 300 mg, Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib, Hyperglycemic clamp
- Keywords
- Insulin resistance, Type 2 diabetes, Hyperinsulinemia, Obesity, Overweight, Healthy volunteers
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Obesity, Overweight, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpelisib 300 mgDrug
Also called Piqray
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 alpelisibDiagnostic 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 clampDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Lean (healthy control) group | Experimental | Healthy volunteers with body mass index of 18.0-24.9 kg/m2, hemoglobin A1c < 6.5%, and fasting plasma glucose < 126 mg/dL Receives: Drug: Alpelisib 300 mg; Diagnostic Test: Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib; Diagnostic Test: Hyperglycemic clamp |
| Overweight group | Experimental | Volunteers with body mass index of 25.0-29.9 kg/m2, hemoglobin A1c < 6.5%, and fasting plasma glucose < 126 mg/dL Receives: Drug: Alpelisib 300 mg; Diagnostic Test: Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib; Diagnostic Test: Hyperglycemic clamp |
| Obesity group | Experimental | Volunteers with body mass index of 30.0-45.0 kg/m2, hemoglobin A1c < 6.5%, and fasting plasma glucose < 126 mg/dL Receives: Drug: Alpelisib 300 mg; Diagnostic Test: Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib; Diagnostic Test: Hyperglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 17 hours after dosing alpelisib
Secondary outcomes (4)
Serum insulin level
Serum insulin levels during steady-state period of hyperglycemic clamp and in response to alpelisib following an overnight fast and MMTT
Measured: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Serum C-peptide level
Serum C-peptide levels during steady-state period of hyperglycemic clamp and in response to alpelisib following an overnight fast and MMTT
Measured: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Insulin secretion rate (ISR)
Calculated from individual insulin levels using C-peptide deconvolution during hyperglycemic clamp steady state and MMTT
Measured: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Insulin clearance rate (ICR)
Calculated from individual insulin levels using C-peptide deconvolution during hyperglycemic clamp steady state and MMTT
Measured: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start2 Sep 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pisa
- Responsible party
- Principal investigator, Joshua Cook, Columbia University
- Investigators
- Joshua R Cook, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778524
- Sponsor's protocol ID
- ACYY1444
- Other IDs
- K23DK140614
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic information (sex, age range, BMI range) and all Primary and Secondary outcome measures
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpelisib Challenge Test (ACT) for Assessment of Pancreatic β-Cell Reserve, Pilot & Feasibility Study
- ClinicalTrials.gov ID
- NCT07778524
- Acronym / sponsor ID
- ACYY1444
- Keywords
- Insulin resistance, Type 2 diabetes, Hyperinsulinemia, Obesity, Overweight, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pisa
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes results from a combination of insulin resistance and failure of pancreatic beta cells to produce sufficient insulin to compensate for it. Beta cell failure is therefore central to type 2 diabetes pathophysiology, and assessment of beta-cell reserve carries prognostic significance for likelihood of progression to type 2 diabetes. Beta-cell reserve may also serve as a useful clinical endpoint for the prevention or treatment of type 2 diabetes. The gold standard for measuring beta-cell reserve is the hyperglycemic clamp technique, which quantifies insulin secretion in response to hyperglycemia induced by exogenous glucose infusion. The hyperglycemic clamp, however, is technically challenging and not suitable for large-scale use, including in many research settings. As such, oral-based methods such as the oral glucose tolerance test (OGTT) and mixed-meal tolerance test (MMTT) have been developed to assess beta-cell reserve. Although these measures are useful, they come with important limitations. The investigators therefore wish to improve upon these oral methods by imposing a near-maximal beta-cell challenge during MMTT. The investigators have designed the Alpelisib Challenge Test (ACT) for this purpose, as alpelisib induces temporary, high-grade insulin resistance that will then allow a more accurate assessment of insulin-secretory capacity during MMTT. Study volunteers will be admitted to the inpatient clinical research unit for one overnight, 30-hour stay. On the morning of Study Day 1, they will undergo the gold-standard hyperglycemic clamp technique to assess beta-cell reserve. Then, at bedtime, they will take a single dose of alpelisib 300 mg followed by measurement of insulin secretion during MMTT on the morning of Study Day 2. This study can therefore determine the potential validity of the ACT by determining correlation coefficients with beta-cell reserve as measured during the hyperglycemic clamp.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean (healthy control) group | Experimental | Drug: Alpelisib 300 mg, Diagnostic Test: Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib, Diagnostic Test: Hyperglycemic clampHealthy volunteers with body mass index of 18.0-24.9 kg/m2, hemoglobin A1c < 6.5%, and fasting plasma glucose < 126 mg/dL |
| Overweight group | Experimental | Drug: Alpelisib 300 mg, Diagnostic Test: Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib, Diagnostic Test: Hyperglycemic clampVolunteers with body mass index of 25.0-29.9 kg/m2, hemoglobin A1c < 6.5%, and fasting plasma glucose < 126 mg/dL |
| Obesity group | Experimental | Drug: Alpelisib 300 mg, Diagnostic Test: Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib, Diagnostic Test: Hyperglycemic clampVolunteers with body mass index of 30.0-45.0 kg/m2, hemoglobin A1c < 6.5%, and fasting plasma glucose < 126 mg/dL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (75 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpelisib 300 mgAlso: PiqrayAll participants will ingest one dose of alpelisib 300 mg (2 x 150-mg tablets) at 23:00 on Study Day 1 | Drug | Lean (healthy control) group, Obesity group, Overweight group |
| Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisibAll participants will ingest standardized mixed meals of Nestlé BOOST Plus on the morning of Study Day 2 after taking alpelisib the previous evening | Diagnostic test | Lean (healthy control) group, Obesity group, Overweight group |
| Hyperglycemic clampAll 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. | Diagnostic test | Lean (healthy control) group, Obesity group, Overweight group |
Primary outcome
Correlation coefficient between clamp and ACT/MMTT
Time frame: Up to 17 hours after dosing alpelisib
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
4 secondary outcomes
Serum insulin level
Time frame: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Serum C-peptide level
Time frame: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Insulin secretion rate (ISR)
Time frame: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Insulin clearance rate (ICR)
Time frame: After 2-3 hours of hyperglycemic clamp and up to 17 hours after alpelisib dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. Demographic information (sex, age range, BMI range) and all Primary and Secondary outcome measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua R Cook, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alpelisib 300 mg, Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib and Hyperglycemic clamp in people with Insulin Resistance and Type 2 Diabetes, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 75 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua R Cook, MD, PhD (2123052663, jrc2175@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between clamp and ACT/MMTT (time frame: Up to 17 hours after dosing alpelisib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.