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Alpha-Lipoic Acid + Mirabegron for Obesity

Phase 2
Waitlist Available
Led By Aaron M Cypess, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult subjects aged 18 - 65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after intervention
Awards & highlights

Study Summary

This trial will study how a drug and a supplement can help people with obesity process food. Participants will stay in the clinic and take the drugs at home, with tests and scans.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to ALA or MG if sensitive to these substances. Since participants have various health screenings before taking part in the trial, any significant side effects related to organ functions would likely be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
changes in the Insulin sensitivity index (SI) obtained from FSIGT
Secondary outcome measures
Maximum observed plasma concentration of ALA (Cmax), time to maximum observed plasma concentration of ALA (Tmax), and area under the concentration-time curve.

Trial Design

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.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,360 Previous Clinical Trials
4,314,792 Total Patients Enrolled
446 Trials studying Obesity
588,878 Patients Enrolled for Obesity
Aaron M Cypess, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Alpha-lipoic acid (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05713799 — Phase 2
Obesity Research Study Groups: MG+ALA, MG+Placebo
Obesity Clinical Trial 2023: Alpha-lipoic acid Highlights & Side Effects. Trial Name: NCT05713799 — Phase 2
Alpha-lipoic acid (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05713799 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can participate in this research study?

"To be considered for inclusion in this medical study, patients must demonstrate signs of insulin resistance and adhere to the age requirement (18-65). Approximately 60 persons will partake in this research."

Answered by AI

Is the age requirement for this trial more than 30 years?

"Data from this clinical trial suggests that the ideal population for enrolment consists of individuals aged 18 to 65. However, there are 211 trials available to minors and 643 studies focusing on seniors."

Answered by AI

Is the combination of magnesium and alpha lipoic acid accepted by the FDA?

"Despite not having clinical evidence of efficacy, there is enough data to suggest that MG+ALA has a level 2 safety rating."

Answered by AI

Are there any slots available in this trial for potential participants?

"The trial is no longer actively enrolling patients. It was initially posted on February 9th, 2023 and last modified on the 3rd of February, 2023. However, there are many other clinical trials currently recruiting individuals to participate in their studies."

Answered by AI

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
2024. "Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05713799.
~40 spots leftby Mar 2026
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