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New treatment option for Insulin Resistance
Official title Human Models of Selective Insulin Resistance: Alpelisib, Part I
ClinicalTrials.gov ID: NCT06354088
What this study is testing
What is Alpelisib 300 mg?
Alpelisib 300 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for insulin resistance.
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 goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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 written and spoken English and/or Spanish
- Body mass index of:
- For Group IS: BMI 18-25 kg/m2
- For Group IR: BMI 30-45 kg/m2
You likely can't join if
- Inability to provide informed consent in English or Spanish
- Concerns arising at screening visit:
- Abnormal vital signs: (1) Systolic blood pressure \ 160 mm Hg and/or (2) Diastolic blood pressure \ 100 mm Hg and/or (3) Abnormal resting heart rate...
- Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant, including liver function abnormalities (either of...
- Laboratory evidence of diabetes mellitus: (1) Hemoglobin A1c ≥ 6.5%, and/or (2) Fasting plasma glucose ≥ 126 mg/dL
- Reproductive concerns i. Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential ii. Women currently pregnant iii. Women...
See the full eligibility criteria
- Adults aged 18-70 years
- Able to understand written and spoken English and/or Spanish
- Body mass index of:
- For Group IS: BMI 18-25 kg/m2
- For Group IR: BMI 30-45 kg/m2
- Evidence of insulin sensitivity or insulin resistance:
- Insulin sensitive (for Group IS) defined as all of the following: (1) Fasting serum insulin ≤ 10 µIU/mL, (2) Absence of dysglycemia (fasting plasma glucose \< 100 mg/dL and hemoglobin A1c \< 5.7%), (3) Homeostasis Model...
- Insulin resistant (for Group IR) defined as fasting serum insulin ≥ 13 µIU/mL plus at least one of the following: (1) Presence of prediabetic state (fasting plasma glucose 100-125 mg/dL and/or hemoglobin A1c 5.7-6.4%)...
- Inability to provide informed consent in English or Spanish
- Concerns arising at screening visit:
- Abnormal vital signs: (1) Systolic blood pressure \ 160 mm Hg and/or (2) Diastolic blood pressure \ 100 mm Hg and/or (3) Abnormal resting heart rate \< 55 bpm (except at PI's discretion) or ≥ 110 bpm
- Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant, including liver function abnormalities (either of the following): (1) Transaminases (AST or ALT) \> 3.0 x the upper limit...
- Laboratory evidence of diabetes mellitus: (1) Hemoglobin A1c ≥ 6.5%, and/or (2) Fasting plasma glucose ≥ 126 mg/dL
- Reproductive concerns i. Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential ii. Women currently pregnant iii. Women currently breastfeeding
- Concerns related to glucose metabolism
- History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes)
- History of gestational diabetes mellitus within the previous 5 years
- Use of most antidiabetic medications (other than metformin) within the 90 days prior to screening: thiazolidinediones, sulfonylureas, meglitinides, dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1...
- Concerns related to lipid metabolism
- Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia in the participant or a first-degree relative
- Use of certain lipid-lowering drugs within 14 d prior to screening visit: fibrates (e.g., fenofibrate, gemfibrozil), prescription-strength omega-3 fatty acids (e.g., icosapent ethyl), high-dose niacin (\>100 mg daily)
- Known, documented history, at the time of screening, of any of the following medical conditions:
- Significant cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)
- Severe liver disease, including advanced fibrosis (e.g., fibrosis score F3-F4 by vibration-controlled transient elastography) and cirrhosis
- Psychiatric diseases causing functional impairment that: (1) Are or have been decompensated within 1 year of screening, and/or (2) Require use of anti-dopaminergic antipsychotic drugs associated with significant weight...
- 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 and differentiated thyroid cancer (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 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 use of tobacco, either daily or an average of at least 1 cigarette per day, and/or nicotine vaping more than 1 day per week
- 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 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, cow dairy, or gluten), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically...
- Dietary restrictions (e.g., vegan, kosher, halal) on gelatin present in overencapsulation
- Concurrent enrollment in another clinical study of any investigational drug/biologic therapy within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.
- Prior participation in other studies led by Dr. Cook (PI) is excluded from this prohibition according to his medical/scientific judgment.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.