Insulin ResistancePhase 1NCT05733455
Effect of Alpelisib in Healthy Volunteers
A Phase 1 study testing Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg), FreeStyle Libre Pro and Oral glucose tolerance test (OGTT) with Trutol glucose beverage in people with Insulin Resistance and Hyperinsulinemia, run by Columbia University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a single dose of the phosphoinositide-3-kinase (PI3K) inhibitor alpelisib versus placebo in healthy volunteers. The main questions it aims to answer are the impact of acute alpelisib-induced insulin resistance on parameters of glucose and lipid metabolism (how healthy people… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Hyperinsulinemia, Dyslipidemias
- What is being tested?
- Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg), FreeStyle Libre Pro and Oral glucose tolerance test (OGTT) with Trutol glucose beverage
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 1 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years, using highly effective contraception if of childbearing potential
- Able to understand written and spoken English and/or Spanish
- Body mass index of 18.0-26.9 kg/m2
- Healthy, as determined by screening assessments and Principal Investigator's (PI's) clinical/scientific judgment. "Healthy" status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead EKG, and laboratory tests on blood and urine.
Who cannot join
- Inability to provide informed consent in English or Spanish
- Concerns arising at screening visit (any of the following):
- Unwillingness to fast (except water) for up to 15 hours
- Documented weight change of ≥ 3.0% of baseline within the previous 6 months
- Abnormal blood pressure
- Systolic blood pressure < 90 mm Hg or > 160 mm Hg, and/or
Show all 53Show fewer
- Diastolic blood pressure < 60 mm Hg or > 100 mm Hg
- Abnormal resting heart rate ≤ 60 bpm or ≥ 100 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
- Abnormal screening electrocardiogram (or if on file, performed within previous 90 d)
- Non-sinus rhythm
- Significant QTc prolongation (≥ 480 ms)
- New or previously unknown ischaemic changes that persist on repeat EKG:
- ST elevations
- T-wave inversions
- Abnormal screening serum electrolytes and/or liver function tests
- Laboratory evidence of prediabetic state or diabetes mellitus:
- Hemoglobin A1c ≥ 5.7%, and/or
- Fasting plasma glucose ≥ 100 mg/dL
- Abnormal fasting lipids at screening (either of the following)
- Triglycerides ≥ 150 mg/dL
- LDL-cholesterol ≥ 160 mg/dL
- Positive qualitative human chorionic gonadotropin beta subunit (β-hCG) (i.e., pregnancy test) in women of childbearing potential
- COVID-19 precautions
- Unwillingness to comply with masking requirements per hospital policy
- Active, documented COVID-19 at any time after screening through study completion
- Reproductive concerns
- Women of childbearing potential not using highly effective contraception, defined as:
- Surgical sterilization (e.g., bilateral tubal occlusion, bilateral oophorectomy and/or salpingectomy, hysterectomy)
- Combined oral contraceptive pills taken daily, including during the study
- Intrauterine device (levonorgestrel-eluting or copper) active at the time of the study
- Medroxyprogesterone acetate (Depo-Provera®) injection active at the time of the study
- Etonogestrel implants (e.g., Implanon®, etc.) active at the time of the study
- Norelgestromin/ethinyl estradiol transdermal system (e.g., Ortho-Evra®) active at the time of the study
- Women currently pregnant
- Women currently breastfeeding
- Any clinically relevant history or the presence of any active or chronic disease, including respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc. disease or diseases except for:
- Osteoarthritis, not using chronic anti-inflammatory medications
- Non-melanoma skin cancer, localized and not receiving systemic therapy
- N.B. Minor chronic health problems that do not impair overall health/functional status and are judged unlikely to interfere with study conduct or data analysis may be permitted at the discretion of the PI
- Currently taking any prescription medications other than vitamins or other nutritional supplements, subject to review by the PI
- o Any participant using biotin (vitamin B7) at >1000 international units per day must not take it for 3 d prior to any study blood draw due to interference with laboratory assays
- Dermatologic concerns
- History of cutaneous and/or mucosal eruptive reactions to food or drugs, including, but not limited to, rash or urticaria
- Active skin conditions requiring ongoing care by a dermatologist except for localized non-melanoma skin cancer (not receiving systemic therapy)
- Clinical concern for alcohol overuse at screening and/or by participant's report of consuming more than 14 standard drinks per week for males or more than 7 standard drinks per week for females
- Current use of illicit drugs
- Tobacco smoking currently or within the previous 6 months
- History of or ongoing febrile illness within 30 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 or cow dairy), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
- Dietary restrictions (e.g.., vegan, kosher, halal) on gelatin present in overencapsulation
- Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Insulin Resistance in the Pathogenesis of Non-Alcoholic Fatty Liver Disease: Alpelisib Pilot & Feasibility Study
The goal of this clinical trial is to test a single dose of the phosphoinositide-3-kinase (PI3K) inhibitor alpelisib versus placebo in healthy volunteers. The main questions it aims to answer are the impact of acute alpelisib-induced insulin resistance on parameters of glucose and lipid metabolism (how healthy people respond to temporary insulin resistance so that the investigators can see what happens to how the liver handles fat and sugar).
Participants will:
Read more
- Consume their total calculated daily caloric needs in nutritional supplements, divided in three meals, and otherwise fast for 24 hours
- Take a dose of alpelisib 300 mg or placebo at bedtime
- Wear a continuous glucose monitor for 72 hours
- Participate in an oral glucose tolerance test (OGTT)
Researchers will compare blood tests before and during OGTT in participants randomized (like the flip of a coin) to alpelisib versus placebo to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B).
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is an under-appreciated complication of lipid dysmetabolism in type 2 diabetes (T2DM). Although it appears that insulin resistance (IR) is a mechanism common to both, the mechanisms linking IR to unhealthy fat accumulation in liver remains unclear. "Pure" IR would be expected to disinhibit hepatic glucose production while dampening hepatic triglyceride (TG) biosynthesis, but the excessive hepatic de novo lipogenesis (DNL) of IR-associated NAFLD (IR-NAFLD) suggests that hepatic IR is "selective." However, the concept of IR selectivity is controversial, and because of clinical heterogeneity, lead-time discrepancies, co-morbidities, and medication effects, parsing out this pathophysiologic conundrum in humans is challenging. The investigators ultimately plan to test whether the multifactorial IR in patients with NAFLD is selective by determining if inducing a discrete, "pure" form of IR, via pharmacologic inhibition of phosphoinositide-3-kinase (PI3K) with alpelisib, attenuates excessive DNL. However, because of the potential toxicities of alpelisib, the investigators first must test whether they can induce IR with a single dose. In order to ensure participants' safety, the investigators propose herein to perform a randomized, placebo-controlled, pilot \& feasibility study of a single dose of alpelisib in healthy volunteers. Following a baseline blood draw on Day 1, participants will be fitted with a continuous glucose monitor. Once lab test results are confirmed as non-exclusionary, randomized participants will be instructed on Day 3 to consume their calculated total daily caloric needs in the form of a nutritional beverage, divided evenly over three meals, and otherwise will fast. On the evening of Day 3, participants will ingest a single dose either of placebo or alpelisib. The following morning (Day 4), about 10 hours later, blood will be drawn to check fasting levels of glucose, insulin, and certain lipid/lipoprotein parameters; the continuous glucose monitor will be removed at that point. Participants will then undergo an oral glucose tolerance test (OGTT) during which investigators will measure glucose, insulin, and lipid (triglycerides, free fatty acids) levels. If the investigators are able to determine reliable induction after a single dose of alpelisib, they will be able to move on to test its effect on volunteers with IR-NAFLD.
- Conditions
- Insulin Resistance, Hyperinsulinemia, Dyslipidemias
- Being tested
- Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg), Placebo (microcrystalline cellulose), 2 capsules, FreeStyle Libre Pro, Oral glucose tolerance test (OGTT) with Trutol glucose beverage, BOOST Plus nutritional beverage
- Keywords
- Insulin resistance, Hyperinsulinemia, Diabetes, Non-alcoholic fatty liver disease
- Medical subject headings
- Insulin Resistance, Hyperinsulinism, Dyslipidemias, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg)Drug
Also called Piqray
Participants will ingest two overencapsulated tablets of alpelisib at 23:00, along with a saltine cracker.
Placebo (microcrystalline cellulose), 2 capsulesDrug
Participants will ingest two capsules filled with microcrystalline cellulose at 23:00, along with a saltine cracker.
FreeStyle Libre ProDevice
Continuous glucose monitoring for 24 hours (double blinded)
Oral glucose tolerance test (OGTT) with Trutol glucose beverageDiagnostic test
Participants will drink Trutol glucose beverage (D-glucose 75 g in 10 fl oz) and blood will be sampled at baseline and at 15, 30, 60, 90, 120, 150, and 180 minutes.
BOOST Plus nutritional beverageDietary supplement
Participants will consume a quantity of BOOST Plus calculated to match their daily caloric needs, divided over three liquid meals.
| Study group | Role | What they receive |
|---|---|---|
| Alpelisib treatment | Experimental | Participants will ingest a single dose of alpelisib 300 mg (two overencapsulated 150-mg tablets) Receives: Drug: Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg); Device: FreeStyle Libre Pro; Diagnostic Test: Oral glucose tolerance test (OGTT) with Trutol glucose beverage; Dietary Supplement: BOOST Plus nutritional beverage |
| Placebo treatment | Placebo comparator | Participants will ingest a single dose of placebo (two capsules filled with microcrystalline cellulose) Receives: Drug: Placebo (microcrystalline cellulose), 2 capsules; Device: FreeStyle Libre Pro; Diagnostic Test: Oral glucose tolerance test (OGTT) with Trutol glucose beverage; Dietary Supplement: BOOST Plus nutritional beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose
Fasting plasma glucose (units: mg/dL) after a single dose of alpelisib vs placebo.
Measured: Day 4 (10 hours after dose)
Fasting serum insulin
Fasting serum insulin (units: micro-international units per milliliter, µIU/mL) levels after a single dose of alpelisib vs placebo.
Measured: Day 4 (10 hours after dose)
Fasting serum C-peptide
Fasting serum C-peptide (units: ng/mL) after a single dose of alpelisib vs placebo.
Measured: Day 4 (10 hours after dose)
Secondary outcomes (11)
Overnight glucose profile
Glucose levels (units: mg/dL) serially sampled in interstitial fluid by continuous glucose monitor
Measured: Days 3-4 (Approximately 24 hours)
Plasma glucose levels during OGTT
Measurement of plasma glucose levels (units: mg/dL) during OGTT in alpelisib vs placebo
Measured: Day 4 (Up to 180 minutes from the start of the procedure)
Plasma glucose area under the curve (AUC) during OGTT
Plasma glucose AUC (units: arbitrary units) during OGTT in alpelisib vs placebo
Measured: Day 4 (Up to 180 minutes from the start of the procedure)
Serum insulin levels during OGTT
Measurement of serum insulin levels (units: µIU/mL) during OGTT in alpelisib vs placebo
Measured: Day 4 (Up to 180 minutes from the start of the procedure)
Serum insulin area under the curve (AUC) during OGTT
Serum insulin AUC (units: arbitrary units) during OGTT in alpelisib vs placebo
Measured: Day 4 (Up to 180 minutes from the start of the procedure)
Serum triglyceride levels during OGTT
Measurement of serum triglyceride levels (units: mg/dL) during OGTT in alpelisib vs placebo
Measured: Day 4 (Up to 180 minutes from the start of the procedure)
Serum free fatty acid levels during OGTT
Measurement of serum free fatty acid levels (units: mmol/L) during OGTT in alpelisib vs placebo
Measured: Day 4 (Up to 180 minutes from the start of the procedure)
Fasting serum or plasma apolipoprotein B levels
Measurement of serum or plasma apolipoprotein B (units: mg/dL) in alpelisib vs placebo
Measured: Day 4 (10 hours after dose)
Fasting serum total cholesterol levels
Measurement of fasting serum total cholesterol (units: mg/dL) in alpelisib vs placebo
Measured: Day 4 (10 hours after dose)
Fasting serum high-density lipoprotein (HDL) cholesterol levels
Measurement of fasting serum HDL cholesterol (units: mg/dL) in alpelisib vs placebo
Measured: Day 4 (10 hours after dose)
Fasting serum low-density lipoprotein (LDL) cholesterol levels
Measurement of fasting serum LDL cholesterol (units: mg/dL) in alpelisib vs placebo
Measured: Day 4 (10 hours after dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start9 May 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- 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
- NCT05733455
- Sponsor's protocol ID
- AAAU3423
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Blood samples will be banked in our Insulin Resistance Biobank and will be made available to other researchers for legitimate research purposes upon request. Associated data will be shared along with specimens in the smallest possible quantity and on a need-to-know basis. No Protected Health Information (PHI) will ever be disclosed to other researchers. All requests will be reviewed by the PI for scientific merit and samples/data will be transferred only upon completion of an Institutional Review Board-approved Material Transfer Agreement (MTA) and/or Data Use Agreement (DUA), as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in the Pathogenesis of Non-Alcoholic Fatty Liver Disease: Alpelisib Pilot & Feasibility Study
- ClinicalTrials.gov ID
- NCT05733455
- Acronym / sponsor ID
- AAAU3423
- Conditions
- Insulin Resistance, Hyperinsulinemia, Dyslipidemias
- Keywords
- Insulin resistance, Hyperinsulinemia, Diabetes, Non-alcoholic fatty liver disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 Feb 2023 (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 clinical trial is to test a single dose of the phosphoinositide-3-kinase (PI3K) inhibitor alpelisib versus placebo in healthy volunteers. The main questions it aims to answer are the impact of acute alpelisib-induced insulin resistance on parameters of glucose and lipid metabolism (how healthy people respond to temporary insulin resistance so that the investigators can see what happens to how the liver handles fat and sugar).
Participants will:
- Consume their total calculated daily caloric needs in nutritional supplements, divided in three meals, and otherwise fast for 24 hours
- Take a dose of alpelisib 300 mg or placebo at bedtime
- Wear a continuous glucose monitor for 72 hours
- Participate in an oral glucose tolerance test (OGTT)
Researchers will compare blood tests before and during OGTT in participants randomized (like the flip of a coin) to alpelisib versus placebo to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B).
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is an under-appreciated complication of lipid dysmetabolism in type 2 diabetes (T2DM). Although it appears that insulin resistance (IR) is a mechanism common to both, the mechanisms linking IR to unhealthy fat accumulation in liver remains unclear. "Pure" IR would be expected to disinhibit hepatic glucose production while dampening hepatic triglyceride (TG) biosynthesis, but the excessive hepatic de novo lipogenesis (DNL) of IR-associated NAFLD (IR-NAFLD) suggests that hepatic IR is "selective." However, the concept of IR selectivity is controversial, and because of clinical heterogeneity, lead-time discrepancies, co-morbidities, and medication effects, parsing out this pathophysiologic conundrum in humans is challenging. The investigators ultimately plan to test whether the multifactorial IR in patients with NAFLD is selective by determining if inducing a discrete, "pure" form of IR, via pharmacologic inhibition of phosphoinositide-3-kinase (PI3K) with alpelisib, attenuates excessive DNL. However, because of the potential toxicities of alpelisib, the investigators first must test whether they can induce IR with a single dose. In order to ensure participants' safety, the investigators propose herein to perform a randomized, placebo-controlled, pilot \& feasibility study of a single dose of alpelisib in healthy volunteers. Following a baseline blood draw on Day 1, participants will be fitted with a continuous glucose monitor. Once lab test results are confirmed as non-exclusionary, randomized participants will be instructed on Day 3 to consume their calculated total daily caloric needs in the form of a nutritional beverage, divided evenly over three meals, and otherwise will fast. On the evening of Day 3, participants will ingest a single dose either of placebo or alpelisib. The following morning (Day 4), about 10 hours later, blood will be drawn to check fasting levels of glucose, insulin, and certain lipid/lipoprotein parameters; the continuous glucose monitor will be removed at that point. Participants will then undergo an oral glucose tolerance test (OGTT) during which investigators will measure glucose, insulin, and lipid (triglycerides, free fatty acids) levels. If the investigators are able to determine reliable induction after a single dose of alpelisib, they will be able to move on to test its effect on volunteers with IR-NAFLD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpelisib treatment | Experimental | Drug: Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg), Device: FreeStyle Libre Pro, Diagnostic Test: Oral glucose tolerance test (OGTT) with Trutol glucose beverage, Dietary Supplement: BOOST Plus nutritional beverageParticipants will ingest a single dose of alpelisib 300 mg (two overencapsulated 150-mg tablets) |
| Placebo treatment | Placebo comparator | Drug: Placebo (microcrystalline cellulose), 2 capsules, Device: FreeStyle Libre Pro, Diagnostic Test: Oral glucose tolerance test (OGTT) with Trutol glucose beverage, Dietary Supplement: BOOST Plus nutritional beverageParticipants will ingest a single dose of placebo (two capsules filled with microcrystalline cellulose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years, using highly effective contraception if of childbearing potential
- Able to understand written and spoken English and/or Spanish
- Body mass index of 18.0-26.9 kg/m2
- Healthy, as determined by screening assessments and Principal Investigator's (PI's) clinical/scientific judgment. "Healthy" status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead EKG, and laboratory tests on blood and urine.
Key exclusion criteria (53 listed)
- Inability to provide informed consent in English or Spanish
- Concerns arising at screening visit (any of the following):
- COVID-19 precautions
- Reproductive concerns
- Any clinically relevant history or the presence of any active or chronic disease, including respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc. disease or diseases except for:
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 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg)Also: PiqrayParticipants will ingest two overencapsulated tablets of alpelisib at 23:00, along with a saltine cracker. | Drug | Alpelisib treatment |
| Placebo (microcrystalline cellulose), 2 capsulesParticipants will ingest two capsules filled with microcrystalline cellulose at 23:00, along with a saltine cracker. | Drug | Placebo treatment |
| FreeStyle Libre ProContinuous glucose monitoring for 24 hours (double blinded) | Device | Alpelisib treatment, Placebo treatment |
| Oral glucose tolerance test (OGTT) with Trutol glucose beverageParticipants will drink Trutol glucose beverage (D-glucose 75 g in 10 fl oz) and blood will be sampled at baseline and at 15, 30, 60, 90, 120, 150, and 180 minutes. | Diagnostic test | Alpelisib treatment, Placebo treatment |
| BOOST Plus nutritional beverageParticipants will consume a quantity of BOOST Plus calculated to match their daily caloric needs, divided over three liquid meals. | Dietary supplement | Alpelisib treatment, Placebo treatment |
Primary outcome
Fasting plasma glucose
Time frame: Day 4 (10 hours after dose)
Fasting plasma glucose (units: mg/dL) after a single dose of alpelisib vs placebo.
Fasting serum insulin
Time frame: Day 4 (10 hours after dose)
Fasting serum insulin (units: micro-international units per milliliter, µIU/mL) levels after a single dose of alpelisib vs placebo.
Fasting serum C-peptide
Time frame: Day 4 (10 hours after dose)
Fasting serum C-peptide (units: ng/mL) after a single dose of alpelisib vs placebo.
11 secondary outcomes
Overnight glucose profile
Time frame: Days 3-4 (Approximately 24 hours)
Plasma glucose levels during OGTT
Time frame: Day 4 (Up to 180 minutes from the start of the procedure)
Plasma glucose area under the curve (AUC) during OGTT
Time frame: Day 4 (Up to 180 minutes from the start of the procedure)
Serum insulin levels during OGTT
Time frame: Day 4 (Up to 180 minutes from the start of the procedure)
Serum insulin area under the curve (AUC) during OGTT
Time frame: Day 4 (Up to 180 minutes from the start of the procedure)
Serum triglyceride levels during OGTT
Time frame: Day 4 (Up to 180 minutes from the start of the procedure)
Serum free fatty acid levels during OGTT
Time frame: Day 4 (Up to 180 minutes from the start of the procedure)
Fasting serum or plasma apolipoprotein B levels
Time frame: Day 4 (10 hours after dose)
Fasting serum total cholesterol levels
Time frame: Day 4 (10 hours after dose)
Fasting serum high-density lipoprotein (HDL) cholesterol levels
Time frame: Day 4 (10 hours after dose)
Fasting serum low-density lipoprotein (LDL) cholesterol levels
Time frame: Day 4 (10 hours after dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: Yes. Blood samples will be banked in our Insulin Resistance Biobank and will be made available to other researchers for legitimate research purposes upon request. Associated data will be shared along with specimens in the smallest possible quantity and on a need-to-know basis. No Protected Health Information (PHI) will ever be disclosed to other researchers. All requests will be reviewed by the PI for scientific merit and samples/data will be transferred only upon completion of an Institutional Review Board-approved Material Transfer Agreement (MTA) and/or Data Use Agreement (DUA), as appropriate.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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. This study is not recruiting at the moment.
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 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg), FreeStyle Libre Pro and Oral glucose tolerance test (OGTT) with Trutol glucose beverage in people with Insulin Resistance and Hyperinsulinemia, 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 4 inclusion and 53 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: finished, as of the sponsor's last update on 21 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (time frame: Day 4 (10 hours after dose)). The study lists 3 primary outcomes in all. 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 21 Dec 2023.