Clinical trial

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

Opening soon · Phase 2 · 1 countries · Registry ID NCT05713799

Opening soonPhase 2Interventional

What this study is about

Background: Obesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \[MG\]) combined with a supplement (alpha-lipoic acid \[ALA\]) may help. Objective: To learn how MG and ALA can help the body process food. Eligibility: People aged 18 to 65 years with a body mass index between 30 and 45 kg/m2. Design: Participants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician. The study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay. During the clinic stays, participants will undergo many tests: They will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin. They will have imaging scans. They will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe. Participants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionInsulin Resistance, Obesity

Full registry criteria

* 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.

Treatments and study arms

Alpha-lipoic acid

Drug

ALA (2.4g) is in a capsule taken twice per day, once in the morning and once in the evening.

Mirabegron

Drug

Mirabegron (50mg) is a yellow pill taken once per day in the morning.

Placebo

Drug

Placebo will be visibly similar to ALA capsules. They are off-white, clear vegetable-based capsules containing an inert microcrystalline cellulose powder.

Primary outcomes

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)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

National Institutes of Health Clinical Center🇺🇸 Bethesda, Maryland, United States
NIH Clinical Center Office of Patient Recruitment (OPR)Contact