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Studying Brown Adipose Tissue with Mirabegron

This study is looking at how a type of fat called brown adipose tissue (BAT) responds to a medication called Mirabegron. Researchers believe BAT might help burn energy, prevent weight gain, and improve how your body uses insulin. The study will give Mirabegron daily for four weeks to women (100mg) and men (200mg) to see how it changes BAT activity. For men, some will receive Mirabegron and others a placebo (an inactive substance). The main goals are to measure changes in BAT activity and insulin sensitivity after four weeks. This study is for people aged 18-40 with a BMI between 18 and 40. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 participants. It involves different groups (cohorts) of men and women, with some men receiving a placebo.
What's involved
You would undergo screening tests, including medical history, physical exam, blood, urine, and heart tests, and a dietitian interview. There will be an overnight baseline visit with repeat tests, an exercise test, and scans, including one where a radioactive substance is injected. You would take Mirabegron or placebo daily for four weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 4 weeks after treatment begins.

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NCT03049462

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Recruiting
PHASE1Ages 18–40InterventionalBasic science
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~100 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:MirabegronB Complex Plus Vitamin C Tablets

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohorts 1 and 2: Change in BAT metabolic activity
Measured over 4 weeks
+1 more outcome measured

Conditions

Polycystic Ovary Syndrome

Explore related trials

ObesityPolycystic Ovary Syndrome

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Aaron M Cypess, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Ashley M Schmitz, C.R.N.P.
[email protected]
(920) 948-1186
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

have major drug-drug interactions with mirabegron
Prolong QT interval
Alter glucose metabolism or cause insulin resistance (in last six months)
Treat diabetes mellitus
Treat hypertension
Be drugs of abuse 14. Self-reported weight loss or weight gain \> 5% in the preceding 6 months. 15. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months 16. Individuals who spend \>70% of daily hours outdoors since the exposure to varied environmental temperatures will potentially impact the ability to influence and measure BAT activity. 17. Addiction to alcohol or substances of abuse within the last 5 years 18. Self-reported current alcohol consumption of more than 2 servings of alcohol per day 19. Self-reported current use of nicotine and/or tobacco products 20. Has participated in a clinical trial with an investigational or marketed drug within 2 months 21. Have had previous radiation exposure (X-rays, PET scans, etc.) within the last year or anticipate radiation exposure in the upcoming year - clinical and/or research - that would exceed research limits 22. Donated blood within last 2 months 23. Unwilling or unable to eat metabolic meals, as determined by dietitian consult. 24. Any other circumstances or criteria that would preclude safe participation in the study in the clinical judgment of the investigator

What this trial measures

  • Cohorts 1 and 2: Change in BAT metabolic activity4 weeks

    Change in brown adipose tissue (BAT) metabolic activity as measured by 18FFDG PET/CT

  • Cohort 3: Change in insulin sensitivity4 weeks

    Change in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp