Could a supplement and drug combo help treat obesity?
NCT ID NCT05713799
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 60 times
Summary
This Phase 2 trial tests whether combining the supplement alpha-lipoic acid with the drug mirabegron can improve how the body processes sugar in people with obesity. Sixty adults aged 18 to 65 with a BMI between 30 and 45 will take the combination or a placebo for 4 weeks. The study measures changes in insulin sensitivity to see if this approach could lead to a new treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alpha-lipoic acid and mirabegron
- What this could lead to
- If it works, this could point toward a new combination treatment for obesity and insulin resistance that is safe and widely available.
- What could go wrong
- This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The combination may not improve insulin sensitivity more than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Adults 18 to 65 years of age 2. BMI greater than or equal to 30 kg/m\^2 and less than or equal to 45 kg/m\^2 EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components). 2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB). 3. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \>125 mg/dL, and/or an HbA1c test \>6.5%). 4. Elevated resting blood pressure \>140/90 mmHg. 5. Individuals with eGFR \<60 ml/min/1.72 m\^2 and a urinary albumin/creatinine ratio UACR\>300 mg/g. 6. Hypo- or hyper-thyroid disease (TSH \>5.0, or \<0.4 MIU/L) that is controlled for less than one year or someone currently taking thyroid hormone replacement. 7. Anemia, defined by hemoglobin \<11.5 g/dL (females) or \<13.5 g/dL (males); sickle cell anemia or other blood disorders; and/or wound healing problems. 8. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment. 9. A clinically significant abnormal ECG and/or QTc interval above normal 10. Moderate hepatic impairment (Child-Pugh Class B) or above 11. Elevated liver enzymes \>75 U/L (ALT or AST) 12. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics 13. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months. 14. Individuals that have been on a very low-calorie diet (\<800 kcal/d), self-reported weight loss \>5% in the preceding six months, or those taking weight loss medications. 15. History of seizure disorder. 16. Addiction to alcohol or substances of abuse within the last 5 years. 17. Self-reported current alcohol consumption of more than 2 servings of alcohol per day. 18. Self-reported current use of nicotine and/or tobacco products. 19. Current use of any drugs known to: 1. Have major drug-drug interactions with mirabegron or alpha-lipoic acid 2. Be CYP2D6 substrates 3. Prolong QT interval 4. Alter glucose metabolism or cause insulin resistance (in last six months) 5. Treat diabetes mellitus 6. Treat hypertension 7. Be drugs of abuse 20. Inability to provide informed consent. 21. Unwilling or unable to eat metabolic meals, as determined by dietitian consult. 22. Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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