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Not yet recruitingPhase 2

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

Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Physical exams, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will have a physical exam."
  • "They will have blood and urine tests and a test of their heart function."
  • "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."
  • "Participant target enrollment of 48 total otherwise healthy women (n=24) and men (n=24) with obesity who will be given one of two dosing assignments: MG 50 mg/d and ALA 2400 mg/d or MG 50 mg/d + placebo over 4 weeks followed by a 4-26-week washout period, after which time participant cross over to the opposite dosing assignment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how mirabegron, a drug, and alpha-lipoic acid, a supplement, help the body process food. It is for women and men ages 18 to 65 with obesity. The study includes taking pills at home and staying in the clinic for tests.

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....

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 65.
  • Body mass index (BMI), a measure of weight compared with height, from 30 to 45.

Who can't join

  • Allergy to either study treatment or its ingredients; bladder problems; or use of certain medicines for an overactive bladder.
  • Diabetes, blood sugar above the study limits, or use of insulin or other diabetes medicines.
  • Blood pressure above 140/90; heart or kidney disease; abnormal heart rhythm or heart tests; or problems with blood pressure dropping when standing.
  • Certain thyroid problems or use of thyroid hormone medicine; low red blood cell counts or other blood disorders; wound-healing problems; liver problems or high liver tests; or a history of seizures.
  • An infection in the past 4 weeks that caused fever or needed antibiotics; pregnancy; childbirth in the past year; or breastfeeding in the past 12 months.
  • A very low-calorie diet, weight loss of more than 5% in the past 6 months, or use of weight-loss medicine; unwillingness or inability to eat the study meals.
  • Alcohol or drug addiction in the past 5 years; more than 2 alcoholic drinks a day; current nicotine or tobacco use; or use of medicines that conflict with the study, including blood pressure medicines.
  • Unable to give informed consent, meaning understand and agree to the study; or other health problems or factors the study doctor thinks could make participation unsafe or affect the results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MD