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Protocol Details

Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men with Obesity

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Recruitment has not started
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years

Referral Letter Required


Population Exclusion(s)



Insulin Sensitivity;
Insulin Resistance;

Recruitment Keyword(s)



Insulin Resistance;

Investigational Drug(s)

Alpha-lipoic acid

Investigational Device(s)



Drug: Placebo
Drug: Mirabegron
Drug: Alpha-lipoic acid

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases


Obesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron [MG]) combined with a supplement (alpha-lipoic acid [ALA]) may help.


To learn how MG and ALA can help the body process food.


People aged 18 to 65 years with a body mass index between 30 and 40 kg/m2.


Participants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.

The study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.

During the clinic stays, participants will undergo many tests:

They will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.

They will have imaging scans.

They will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.

Participants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine.

They will log their diet, exercise, and sleep.

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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


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

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Aaron M. Cypess, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CRC BG RM 6-3950
(301) 435-9267

Ashley M. Schmitz, C.R.N.P.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CRC BG RM 6-3940
(920) 948-1186

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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