NCT05713799Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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....
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 3 Feb 2023
- Start date
- 9 Nov 2026
- Primary completion date
- 1 Mar 2030
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Diseases
- Obesity
- NCT number
- NCT05713799
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 9 Nov 2026 to the primary completion date, 1 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).
- Hypo- or hyper-thyroid disease (TSH \>5.0, or \<0.4 MIU/L) that is controlled for less than one year or someone currently taking thyroid hormone replacement.
- Individuals that have been on a very low-calorie diet (\<800 kcal/d), self-reported weight loss \>5% in the preceding six months, or those taking weight loss medications.
Other illness
- Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).
- Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment.
- Moderate hepatic impairment (Child-Pugh Class B) or above
- Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics
- History of seizure disorder.
Lab values
- Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \>125 mg/dL, and/or an HbA1c test \>6.5%).
- Individuals with eGFR \<60 ml/min/1.72 m\^2 and a urinary albumin/creatinine ratio UACR\>300 mg/g.
- Anemia, defined by hemoglobin \<11.5 g/dL (females) or \<13.5 g/dL (males); sickle cell anemia or other blood disorders; and/or wound healing problems.
- A clinically significant abnormal ECG and/or QTc interval above normal
- Elevated liver enzymes \>75 U/L (ALT or AST)
- Current use of any drugs known to:
- Have major drug-drug interactions with mirabegron or alpha-lipoic acid
- Be CYP2D6 substrates
- Prolong QT interval
- Alter glucose metabolism or cause insulin resistance (in last six months)
- Treat diabetes mellitus
- Treat hypertension
- Be drugs of abuse
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Elevated resting blood pressure \>140/90 mmHg.
- Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months.
- Addiction to alcohol or substances of abuse within the last 5 years.
- Self-reported current alcohol consumption of more than 2 servings of alcohol per day.
- Self-reported current use of nicotine and/or tobacco products.
- Inability to provide informed consent.
- Unwilling or unable to eat metabolic meals, as determined by dietitian consult.
- Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.
Criteria the registry did not label
- INCLUSION CRITERIA
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults 18 to 65 years of age
- BMI greater than or equal to 30 kg/m\^2 and less than or equal to 45 kg/m\^2
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.