Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
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....
Description
Study Description: This is a single site, Phase II single-blinded, randomized placebo control crossover pilot study. This study aims to explore the effect of adding alphalipoic acid (ALA) to mirabegron (MG) on glucose metabolism and lipolysis rate. 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. Participants will u…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
* 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…
Interventions
- DrugAlpha-lipoic acid
ALA (2.4g) is in a capsule taken twice per day, once in the morning and once in the evening.
- DrugMirabegron
Mirabegron (50mg) is a yellow pill taken once per day in the morning.
- DrugPlacebo
Placebo will be visibly similar to ALA capsules. They are off-white, clear vegetable-based capsules containing an inert microcrystalline cellulose powder.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland