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Polycystic Ovary SyndromePhase 1NCT03049462

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

A Phase 1 study testing Mirabegron and B Complex Plus Vitamin C Tablets in people with Polycystic Ovary Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Mirabegron and B Complex Plus Vitamin C Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteUnited States
Study dates
13 Mar 2017to 26 Aug 2026
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Cohort 1: (complete)
  • Female
  • Age 18-40 years
  • BMI 18.00-40.0 kg/m^2
  • Able to understand the research and willing to sign a written informed consent document
Show all 31Show fewer
  • Cohort 2: (complete)
  • Male
  • Age 18-40 years
  • BMI 18.00-40.0 kg/m^2
  • Able to understand the research and willing to sign a written informed consent document
  • Cohort 3:
  • Female
  • Age 18-40 years
  • BMI 25.0-50.0 kg/m^2 or BMI > 18.5 kg/m^2 with PCOS diagnosis
  • Diagnosis of PCOS based on NIH Criteria; defined by the presence of both clinical and/or biochemical signs of hyperandrogenism and oligo- or chronic anovulation.
  • Women of childbearing potential must agree to use a highly effective method of birth control, confirmed by the Investigator, for at least 3 months prior to the first study visit and continuing throughout the study duration.
  • Highly effective methods of birth control include:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Sexual abstinence, i.e., refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant)
  • Vasectomized sexual partner (provided that partner is the sole sexual partner of the study participant and that the vasectomized partner has received medical assessment of the surgical success)
  • Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for >=12 months prior to the planned date of enrollment without an alternative medical cause.
  • Insulin resistance defined by either
  • HOMA-IR score > 5.9 OR
  • HOMA-IR score > 2.8 and <5.9, with HDL <51 mg/dL OR
  • Fasting Insulin > 10.6 microU/mL
  • Able to understand the research and willing to sign a written informed consent document

Who cannot join

  • Hypersensitivity and associated allergic reactions to mirabegron (or similar drug substances or components)
  • Abnormal bladder function, diagnosis of bladder outlet obstruction, urinary incontinence, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)
  • Type 1 or Type 2 Diabetes mellitus, fasting serum glucose >125 mg/dL, and/or an HbA1c test >6.5%
  • Hypertension, defined as blood pressure (Bullet)140/90 mmHg, based on WHO guidelines (https://www.who.int/news-room/fact-sheets/detail/hypertension)
  • Hypo- or hyper-thyroid disease (TSH >5.0, <0.4 miU/L) that is controlled for less than one year
  • Anemia, defined by hemoglobin < 11.3 g/dL (females) or < 13.8 g/dL (males); sickle cell anemia or other blood disorders; and/or wound healing problems
Show all 30Show fewer
  • Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment
  • A clinically significant abnormal ECG and/or QTc interval above normal
  • Elevated liver enzymes with probable or diagnosed liver disease (other than fatty liver disease)
  • Psychological conditions such as claustrophobia, untreated clinical depression or anxiety, untreated bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study
  • Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics
  • Self-reported intolerance of cold that would prevent the individual from spending several hours in a chilled room with a cooling vest
  • Current use of any drugs known to:
  • 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
  • Self-reported weight loss or weight gain > 5% in the preceding 6 months.
  • Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months
  • 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.
  • Addiction to alcohol or substances of abuse within the last 5 years
  • Self-reported current alcohol consumption of more than 2 servings of alcohol per day
  • Self-reported current use of nicotine and/or tobacco products
  • Has participated in a clinical trial with an investigational or marketed drug within 2 months
  • 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
  • Donated blood within last 2 months
  • Unwilling or unable to eat metabolic meals, as determined by dietitian consult.
  • Any other circumstances or criteria that would preclude safe participation in the study in the clinical judgment of the investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy.

Read more

Objective:

To learn more about how BAT works to burn energy.

Eligibility:

People ages 18-40 with a body mass index between 18 and 40

Design:

Participants will be screened with:

Medical history

Physical exam

Blood, urine, and heart tests

Dietitian interview

Participants will have an overnight baseline visit. This includes:

Repeats of screening tests

Exercise test

Scans. For one scan, a radioactive substance is injected into the arm.

FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other.

Metabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature.

Optional fat biopsy: A small piece of tissue is removed with a needle.

Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo.

All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests.

Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests.

Participants will keep food and medication diaries.

Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.

Read the detailed description

Study Description:

This study is intended to address questions about human brown adipose tissue (BAT). Specifically, we plan to visualize BAT activity with acute cold exposure during drug naive and drug experienced visits. Thus, we will be studying changes in BAT activity from a chronic dosage of mirabegron.

Objectives:

Cohort 1: To measure changes in BAT metabolic activity in women seen after four weeks of daily treatment with the beta3-AR agonist mirabegron.

Cohort 2: To measure changes in BAT metabolic activity in men seen after four weeks of daily treatment with 200 mg of the beta3-AR agonist mirabegron compared to placebo

Cohort 3: To compare the changes in insulin sensitivity in each woman after four weeks of daily treatment with 100 mg of the beta3-AR agonist mirabegron with the changes in insulin sensitivity in each woman after four weeks of daily treatment with placebo

Primary Endpoints:

Cohort 1: The change in detectable cold exposure induced BAT metabolic activity in women, as visualized by F-FDG PET/CT.

Cohort 2: The change in detectable cold exposure induced BAT metabolic activity, as visualized by 18F-FDG PET/CT

Cohort 3: The change in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp, in women after four weeks of daily treatment with 100 mg of the beta3-AR agonist mirabegron with the change in glucose infusion rate after four weeks of daily treatment with placebo

Secondary Endpoints:

  1. To identify changes in metabolic health arising from BAT activation and/or prolonged treatment with regular 100 mg (females) or 200mg (men) doses of mirabegron.
  2. To determine if there is an interaction between (a) BMI and (b) age with respect to the capacity to increase BAT metabolic activity.
  3. To describe the structural and physiological changes in the adipose tissue depots, including cell lineage, size, and inflammation.
  4. To assess whether there are improvements in the liver, including reduced stiffness and quantity of hepatic fat.
Being tested
Mirabegron, B Complex Plus Vitamin C Tablets
Keywords
Brown Adipose Tissue, Energy Expenditure, Energy Metabolism, Obesity
Medical subject headings
Polycystic Ovary Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirabegronDrug

    Women will take 100mg daily for 4 weeks. Men will take 200mg daily for 4 weeks. The medication is available in 50 mg tablets.

  • B Complex Plus Vitamin C TabletsOther

    Males will be randomized to take placebo versus active drug (mirabegron). Those taking placebo will take 4 tablets each day to mirror to active group (taking 4 tablets of 50 mg each).

Study groups in NCT03049462
Study groupRoleWhat they receive
Cohort 1ExperimentalFemales taking 100 mg of mirabegron
Receives: Drug: Mirabegron
Cohort 2AActive comparatorMales taking 200 mg mirabegron
Receives: Drug: Mirabegron
Cohort 2BPlacebo comparatorMales taking placebo drug
Receives: Other: B Complex Plus Vitamin C Tablets
Cohort 3AActive comparatorFemales taking 100 mg of mirabegron
Receives: Drug: Mirabegron
Cohort 3BPlacebo comparatorFemales taking placebo drug
Receives: Other: B Complex Plus Vitamin C Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohorts 1 and 2: Change in BAT metabolic activity

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

    Measured: 4 weeks

  2. Cohort 3: Change in insulin sensitivity

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

    Measured: 4 weeks

Secondary outcomes (3)

  1. Identify changes in metabolic health arising from BAT activation and/or prolonged treatment with mirabegron

    Change in metabolic health parameters including body weight, fat mass, glucose tolerance, changes in levels of hormones, and improved liver function

    Measured: 4 weeks

  2. Cohort 3: Changes in BAT metabolic activity

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

    Measured: 4 weeks

  3. Cohorts 1 and 2: Changes in insulin sensitivity

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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2017
  2. Study start13 Mar 2017
  3. Primary completion26 Aug 2026
  4. Study completion26 Aug 2026

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03049462
Sponsor's protocol ID
170054
Other IDs
17-DK-0054
Status last verified
2 Sep 2026
First submitted
9 Feb 2017
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).

Publications

  • O'Mara AE, Johnson JW, Linderman JD, Brychta RJ, McGehee S, Fletcher LA, Fink YA, Kapuria D, Cassimatis TM, Kelsey N, Cero C, Sater ZA, Piccinini F, Baskin AS, Leitner BP, Cai H, Millo CM, Dieckmann W, Walter M, Javitt NB, Rotman Y, Walter PJ, Ader M, Bergman RN, Herscovitch P, Chen KY, Cypess AM. Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity. J Clin Invest. 2020 May 1;130(5):2209-2219. doi: 10.1172/JCI131126.

    PubMed 31961826

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mirabegron and B Complex Plus Vitamin C Tablets in people with Polycystic Ovary Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 31 inclusion and 30 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 9 Sep 2026. 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?

Cohorts 1 and 2: Change in BAT metabolic activity (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03049462, which also lists 1 linked publication.

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 9 Sep 2026.

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