What is the mechanism of action of this treatment?

Common treatments for Polycystic Ovary Syndrome (PCOS) include oral contraceptives, which regulate menstrual cycles and reduce androgen levels, and insulin-sensitizing agents like metformin, which improve insulin resistance. These treatments are crucial for managing symptoms such as irregular periods, hirsutism, and metabolic issues. Mirabegron, which activates brown adipose tissue to increase energy expenditure, represents a novel approach by potentially addressing obesity and metabolic dysfunctions in PCOS patients. This is significant as it targets the underlying metabolic disturbances, offering a complementary strategy to traditional treatments.

What side effects are associated with this type of intervention?

The most common treatments for PCOS include oral contraceptives, metformin, acarbose, and lifestyle changes. Oral contraceptives can increase the risk of venous thromboembolism, particularly in women over 40 and those with obesity. Metformin may cause gastrointestinal issues such as nausea and diarrhea and has been associated with a modest reduction in testosterone levels. Acarbose can also lead to gastrointestinal side effects like bloating and flatulence. Lifestyle changes, including diet and exercise, generally have minimal side effects but require sustained effort and commitment. While Mirabegron, which activates brown adipose tissue, is not specifically mentioned for PCOS, its side effects in other contexts include increased heart rate and blood pressure.

What prior FDA approvals exist?

The FDA has approved several treatments for PCOS, primarily focusing on managing symptoms such as hyperandrogenism, menstrual irregularities, and metabolic issues. Common treatments include oral contraceptives (OCs) for menstrual regulation and hyperandrogenism, and metformin for insulin resistance and weight management. While Mirabegron, which activates brown adipose tissue to increase energy expenditure, is being studied, there are no specific FDA-approved drugs for PCOS that function through this mechanism. Current treatments mainly address hormonal and metabolic aspects rather than directly targeting energy expenditure through brown adipose tissue activation.

What other types of research exist?

Promising novel alternatives to Mirabegron for PCOS patients include GLP-1 agonists like semaglutide, which is effective in weight management and metabolic improvements. Additionally, myo-inositol, a dietary supplement acting as an insulin sensitizer, has shown efficacy in improving ovulatory frequency and weight loss in PCOS patients.

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Beta3-Adrenergic Receptor Agonist

Mirabegron + B Complex Plus Vitamin C for Brown Adipose Tissue

Phase 1

Recruiting

Led By Aaron M Cypess, M.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Insulin Resistance defined by either: HOMA-IR (a) >5.9 or (b) 2.8 < HOMA-IR < 5.9 with HDL< 51 mg/dL or Fasting Insulin >10.6 microU/mL

Cohort 3: Use of birth control such as intrauterine devices (hormonal or copper), hormonal implants, or oral contraceptives and with stable use for at least 3 months excluding exclusive use of barrier methods

Must not have

Abnormal bladder function, diagnosis of bladder outlet obstruction, urinary incontinence, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)

Elevated blood pressure that is >135/85 mmHg or currently taking antihypertensive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Summary

This trial tests if the drug mirabegron can increase brown fat activity in people aged 18-40 with different body types. The drug helps brown fat burn more energy, which might aid in weight loss and better sugar management.

Who is the study for?

This trial is for men and women aged 18-40 with a BMI of 18-40, who use certain birth control methods. It's not for those with significant weight changes recently, bladder issues, diabetes, high blood pressure, abnormal ECGs or heart conditions, mental health disorders incompatible with the study, substance abuse history within 5 years, excessive alcohol or nicotine use, recent pregnancy or breastfeeding (women only), medication that alters metabolism or energy expenditure.

What is being tested?

Researchers are testing how brown adipose tissue (BAT) helps burn energy using mirabegron pills over four weeks. Men may receive either the drug or a placebo while all women will take mirabegron. Participants undergo various tests including scans and metabolic rate measurements in a special room. They also keep diaries of their food intake and medications.

What are the potential side effects?

Potential side effects include reactions to mirabegron such as increased blood pressure and possible allergic responses if sensitive to this type of medication. The study will closely monitor participants for any adverse effects during the trial period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have insulin resistance based on specific blood test results.

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I have been using a stable form of birth control (not just condoms) for at least 3 months.

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I have been using a reliable birth control method (not just condoms) for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have bladder issues like incontinence or use medication for overactive bladder.

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My blood pressure is above 135/85 mmHg or I am on medication for high blood pressure.

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I have heart, blood pressure, or kidney problems.

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I have an abnormal heart rhythm or take medication that affects my heart's rhythm.

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I cannot tolerate cold due to Raynaud's disease or sensitivity.

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I have high liver enzymes and a liver condition not related to fatty liver disease.

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I do not have psychological conditions that would prevent me from safely participating in this study.

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I do not have infections or issues with wound healing at the cancer site.

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I have lost or gained more than 5% of my weight in the last 6 months.

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I have sickle cell anemia or a blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort 3: Change in insulin sensitivity

Cohorts 1 and 2: Change in BAT metabolic activity

Secondary study objectives

Cohort 3: Changes in BAT metabolic activity

Cohorts 1 and 2: Changes in insulin sensitivity

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

Side effects data

From 2019 Phase 4 trial • 28 Patients • NCT02086188

headache

asthma

diarrhea

gastritis

urinary tract infection

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Mirabegron

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Cohort 1Experimental Treatment1 Intervention

Females taking 100 mg of mirabegron

Group II: Cohort 2AActive Control1 Intervention

Males taking 200 mg mirabegron

Group III: Cohort 3AActive Control1 Intervention

Females taking 100 mg of mirabegron

Group IV: Cohort 2BPlacebo Group1 Intervention

Males taking placebo drug

Group V: Cohort 3BPlacebo Group1 Intervention

Females taking placebo drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirabegron

2008

Completed Phase 4

~18640

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Polycystic Ovary Syndrome (PCOS) include oral contraceptives, which regulate menstrual cycles and reduce androgen levels, and insulin-sensitizing agents like metformin, which improve insulin resistance. These treatments are crucial for managing symptoms such as irregular periods, hirsutism, and metabolic issues. Mirabegron, which activates brown adipose tissue to increase energy expenditure, represents a novel approach by potentially addressing obesity and metabolic dysfunctions in PCOS patients. This is significant as it targets the underlying metabolic disturbances, offering a complementary strategy to traditional treatments.

Salvia miltiorrhiza Extract and Individual Synthesized Component Derivatives Induce Activating-Transcription-Factor-3-Mediated Anti-Obesity Effects and Attenuate Obesity-Induced Metabolic Disorder by Suppressing C/EBPα in High-Fat-Induced Obese Mice.Beneficial Metabolic Effects of Mirabegron In Vitro and in High-Fat Diet-Induced Obese Mice.Antiobesity effects of coumestrol through expansion and activation of brown adipose tissue metabolism.