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Alpha-Lipoic Acid + Mirabegron for Obesity

Phase 2

Waitlist Available

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

Adult subjects aged 18 - 65 years

Be older than 18 years old

Must not have

Individuals with cardiac arrhythmia or abnormal baseline EKG

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after intervention

Summary

This trial will study how a drug and a supplement can help people with obesity process food. Participants will stay in the clinic and take the drugs at home, with tests and scans.

Who is the study for?

This trial is for men and women aged 18-65 with obesity (BMI between 30 and 40 kg/m2) who are generally healthy. It's not for those with severe anemia, low platelets, poor kidney function, recent pregnancy or breastfeeding, liver issues, heart rhythm problems, drug allergies including sulfa drugs, or on certain medications that affect metabolism.

What is being tested?

The study tests if a combination of the supplement alpha-lipoic acid (ALA) and the drug mirabegron (MG), both taken orally with water at home after initial clinic stays and tests, can help process food better in obese individuals. Participants will also take MG plus a placebo during one phase to compare effects.

What are the potential side effects?

Potential side effects may include allergic reactions to ALA or MG if sensitive to these substances. Since participants have various health screenings before taking part in the trial, any significant side effects related to organ functions would likely be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I have an irregular heartbeat or abnormal heart test results.

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I am not taking medication that affects heart rhythm or interacts with specific enzymes.

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I have a history of bladder problems or I'm taking medication for an overactive bladder.

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I am not taking any supplements or medications that affect energy levels, including levothyroxine.

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I have a history of seizures.

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I have diabetes or take medication that could lower my blood sugar.

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My blood counts are low and I may have kidney issues.

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I am not allergic to mirabegron, alpha-lipoic acid, or sulfa drugs.

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My liver function is moderately impaired.

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I cannot take medicine by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after intervention

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

Treatment Details

Study Objectives

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

Primary study objectives

changes in the Insulin sensitivity index (SI) obtained from FSIGT

Secondary study objectives

Maximum observed plasma concentration of ALA (Cmax), time to maximum observed plasma concentration of ALA (Tmax), and area under the concentration-time curve.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MG+ALAActive Control2 Interventions

Participants take mirabegron + alpha lipoic acid daily for 4 weeks. There is testing pre- and post-treatment. Will evaluate the effects of MG+ALA on metabolic heath.

Group II: MG+PlaceboPlacebo Group2 Interventions

Participants take mirabegron + placebo daily for 4 weeks. There is testing pre- and post-treatment. Will evaluate the effects of MG+Placebo on metabolic heath.

0 / 11Eligibility criteria met