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NCT05713799 · ClinicalTrials.gov registry record · Phase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT05713799: Clinical Trial Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT05713799 is a Phase 2 study that has not yet begun recruiting, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05713799, a Phase 2 study, has not yet begun recruiting, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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....
Primary Outcome
Change in the Insulin sensitivity index before and after 4 weeks of MG and ALA minus change in the insulin sensitivity index before and after 4 weeks of MG and placebo. This measures a change in insulin sensitivity index following ALA while controlling for changes in insulin sensitivity index due to placebo.Delta SI = (SI after ALA - SI before ALA)- (SI after placebo - SI before placebo)
Interventions
- DRUG Placebo
- DRUG Mirabegron
- DRUG Alpha-lipoic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 2 |
What is known before NCT05713799 opens enrollment
NCT05713799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05713799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05713799 about?
NCT05713799 is a clinical study titled "Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity". 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 AL...
What is the current status of trial NCT05713799?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-07-15. Estimated completion is 2030-03-01.
What interventions are being tested in trial NCT05713799?
The interventions under investigation include: Placebo (DRUG), Mirabegron (DRUG), Alpha-lipoic acid (DRUG).
Who is sponsoring clinical trial NCT05713799?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05713799's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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