Alpha-Lipoic Acid + Mirabegron for Obesity

Recruiting in Palo Alto (17 mi)

Overseen byAaron M Cypess, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Prior Safety Data

Trial Summary

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

You have a body mass index (BMI) between 30 and 40.

I am between 18 and 65 years old.

Exclusion Criteria

I have an irregular heartbeat or abnormal heart test results.

I am not taking medication that affects heart rhythm or interacts with specific enzymes.

Individuals with significant medical comorbidities that would render the subject s participation unsafe as assessed by the investigator

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Treatment Details

Interventions

Alpha-lipoic acid (Other)
Mirabegron (Other)
Placebo (Other)

Trial OverviewThe study tests if a combination of the supplement alpha-lipoic acid (ALA) and the drug mirabegron (MG), both taken orally with water at home after initial clinic stays and tests, can help process food better in obese individuals. Participants will also take MG plus a placebo during one phase to compare effects.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: MG+ALAActive Control2 Interventions

Participants take mirabegron + alpha lipoic acid daily for 4 weeks. There is testing pre- and post-treatment. Will evaluate the effects of MG+ALA on metabolic heath.

Group II: MG+PlaceboPlacebo Group2 Interventions

Participants take mirabegron + placebo daily for 4 weeks. There is testing pre- and post-treatment. Will evaluate the effects of MG+Placebo on metabolic heath.