Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Feb 3, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether a combination of two substances—mirabegron, which is a medication, and alpha-lipoic acid, a dietary supplement—can help people with obesity process food better. The study aims to find out if this combination can be a safe and effective treatment for those struggling with obesity and related health issues.

To participate in the trial, individuals need to be between 18 and 65 years old and have a body mass index (BMI) between 30 and 40, which indicates obesity. Those interested will undergo various tests, including blood and urine tests, during a two-day stay at the clinic, followed by taking the study drugs at home for about four weeks. Participants will keep a log of their diet, exercise, and sleep, and will return to the clinic for additional testing after the home phase. It’s important to note that certain health conditions or medications may exclude someone from joining the study.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• To be eligible to participate in this study, an individual must meet all of the following criteria:
• • 1. Adult subjects aged 18 - 65 years
• • 2. BMI greater than 30 kg/m2 and less than 40 kg/m2
• EXCLUSION CRITERIA:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that increases risk of hypoglycemia
• • 2. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months (for women only)
• • 3. Hemoglobin \<= 10 g/dl, Platelets \<= 75 x 10\^9 per liter, white blood cell count \<= 4 x 10\^9 per liter) or patients with eGFR \<60 ml/min/1.72 m2 and a Urine Albumin Creatinine Ratio \>300 mg/g
• • 4. Since recent weight loss would change the metabolic rate, subjects that have been on a very low-calorie diet (\<800 kcal/d) within a year or self-reported weight loss \>5% in the preceding six months.
• • 5. Trained athletes
• • 6. History of seizure disorder
• • 7. An active history of abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)
• • 8. History of hypertension or subjects on antihypertensive therapy since the combination therapy on other beta receptors is unknown.
• • 9. Medication that causes QT prolongation, adrenergic agonists, cardiac beta-blockers, calcium channel blockers, insulin resistance (systemic corticosteroids), monoamine oxidase, or medications known to be CYP2D6 substrates
• • 10. Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism, including levothyroxine.
• • 11. Subjects with moderate hepatic impairment (Child-Pugh Class B) or above
• • 12. Unable to take oral medication
• • 13. Individuals with significant medical comorbidities that would render the subject s participation unsafe as assessed by the investigator
• • 14. Individuals with cardiac arrhythmia or abnormal baseline EKG
• • 15. Individuals who have current substance abuse or a psychiatric disorder or any other condition that, in the investigators' opinion, would impede competence, compliance, or participation in the study.
• • 16. Individuals with known allergies to mirabegron and alpha-lipoic acid or sulfa containing drugs
• • 17. Inability to provide informed consent
• • 18. Other factors that the PI will determine to affect the safety or outcome of the study