Alpha-Lipoic Acid + Mirabegron for Obesity
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot participate if you are taking certain medications like those for diabetes, hypertension, or those that affect energy metabolism. It's best to discuss your specific medications with the trial team.
What evidence supports the effectiveness of the drug Alpha-Lipoic Acid for obesity?
Is the combination of Alpha-Lipoic Acid and Mirabegron safe for humans?
Mirabegron, used for overactive bladder, can activate brown fat and improve metabolism, but it may cause cardiovascular issues like increased heart rate and blood pressure. Long-term safety studies are needed, especially for high doses, as it may worsen conditions like atherosclerosis (a disease where plaque builds up in arteries).678910
How does the drug combination of Alpha-Lipoic Acid and Mirabegron for obesity differ from other treatments?
What is the purpose of this trial?
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 40 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.They will log their diet, exercise, and sleep....
Research Team
Aaron M Cypess, M.D.
Principal Investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria
This trial is for men and women aged 18-65 with obesity (BMI between 30 and 40 kg/m2) who are generally healthy. It's not for those with severe anemia, low platelets, poor kidney function, recent pregnancy or breastfeeding, liver issues, heart rhythm problems, drug allergies including sulfa drugs, or on certain medications that affect metabolism.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants take mirabegron + alpha-lipoic acid or mirabegron + placebo daily for 4 weeks. Includes a 2-day clinic stay at the start and end, with outpatient visits 2 weeks after each clinic stay.
Washout
Participants undergo a washout period before crossing over to the other treatment arm.
Treatment Phase 2
Participants cross over to the other treatment arm and take the study drugs for another 4 weeks. Includes a 2-day clinic stay at the start and end, with outpatient visits 2 weeks after each clinic stay.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
Treatment Details
Interventions
- Alpha-lipoic acid
- Mirabegron
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor