Obesity / Mirabegron / Insulin Resistance · Phase 2 Trial

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

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 2 trial investigating the combination of mirabegron and alpha-lipoic acid in adults with obesity and insulin resistance. The study design includes intensive physiologic testing and a crossover structure, but recruitment has not yet begun and no outcome data are available in this registry record.

What was studied

Phase 2, Interventional, Randomized, Crossover, Single masking, Treatment purpose. Insulin Resistance, Obesity; age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: ALA then placebo; Placebo then ALA. Compared with: Mirabegron plus placebo (crossover design implies a second comparator arm, not fully detailed in excerpt). n = 60. 1 site: United States.

Key findings

Safety

No safety, tolerability, or efficacy data are available; outcomes cannot be assessed from this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned Phase 2 interventional trial that has not yet begun recruitment; no results are reported and the study design alone cannot establish efficacy or safety.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Changes in the Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1 (assessed at Insulin sensitivity index measured before and after each intervention in sequen…)

DesignPhase 2, Interventional, Randomized, Crossover, Single masking, Treatment purpose

PopulationInsulin Resistance, Obesity; age from 18 Years; to 65 Years; accepts healthy volunteers

Sample size60

InterventionALA then placebo; Placebo then ALA

ComparatorMirabegron plus placebo (crossover design implies a second comparator arm, not fully detailed in excerpt)

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment60

Study phasePHASE2

Primary outcome measureChanges in Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1

Age eligibility18 to 65 years

BMI eligibility30 to 45 kg/m2

Caveats

This is a registry record; no results are reported and recruitment has not yet begun (status: NOT_YET_RECRUITING).
Sample size justification and statistical power calculation not provided in registry record.
Blinding and allocation concealment procedures not detailed in available registry text.
No safety, tolerability, or efficacy data are available; outcomes cannot be assessed from this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design with planned crossover phases and intensive physiologic testing.

Directness

moderate

Primary outcome measures insulin sensitivity directly via FSIGT, relevant to obesity pathophysiology.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

moderate

Placebo-controlled crossover design reduces bias, but blinding and allocation concealment not detailed.

Sample adequacy

limited

Estimated enrollment 60 participants; sample size justification not provided in registry record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05713799). This is a study registration, not published results. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Insulin Resistance, Obesity. Interventions: DRUG: Alpha-lipoic acid; DRUG: Mirabegron; DRUG: Placebo. Primary outcome measures: Changes in the Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1 , Insulin sensitivity index measured before and after each intervention in sequence. Brief 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....

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityMirabegronInsulin ResistanceNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Alpha-lipoic acidNCT05713799