Alpha-Lipoic Acid and Mirabegron for Obesity and Insulin Resistance

This study is testing if a combination of alpha-lipoic acid (ALA) and mirabegron can help your body process food better, especially if you have obesity and insulin resistance. Researchers want to see if this combination improves insulin sensitivity (how well your body uses insulin to control blood sugar). You might be eligible if you are between 18 and 65 years old and have a Body Mass Index (BMI) between 30 and 45 kg/m². The study aims to enroll 60 participants. The status of this study is currently unclear.

Study design
This is a Phase II, single-blinded (you won't know if you're getting the active treatment or placebo), randomized (assigned by chance), placebo-controlled crossover pilot study. It plans to enroll 48 participants.
What's involved
You will undergo screening, a physical exam, blood and urine tests, a heart function test, and speak with a dietician. You will take either mirabegron with alpha-lipoic acid or mirabegron with a placebo for 4 weeks, followed by a 4-26 week break, then switch to the other treatment for another 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your insulin sensitivity will be measured before and after each 4-week intervention period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05713799

Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity

Not Yet Recruiting
PHASE2Ages 18–65InterventionalTreatment
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~60 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Alpha-lipoic acidMirabegronPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in the Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1
Measured over Insulin sensitivity index measured before and after each intervention in sequence
Insulin Resistance
Obesity
1 sites across 1 states
Maryland1
  • Aaron M Cypess, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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  • Changes in the Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1Insulin sensitivity index measured before and after each intervention in sequence

    Change in the Insulin sensitivity index before and after 4 weeks of MG and ALA minus change in the insulin sensitivity index before and after 4 weeks of MG and placebo. This measures a change in insulin sensitivity index following ALA while controlling for changes in insulin sensitivity index due to placebo.Delta SI = (SI after ALA - SI before ALA)- (SI after placebo - SI before placebo)