NCT05713799Toborzás még nem indult2. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 6.
Rövid összefoglaló (regiszter, angolul)
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....
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2023. febr. 3.
- Kezdés
- 2026. nov. 11.
- Elsődleges befejezés
- 2030. márc. 1.
- Fő szponzor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Betegségek
- Elhízás
- NCT-szám
- NCT05713799
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 60
- 2026. nov. 11. és az elsődleges befejezés (2030. márc. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 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.
Más betegség
- 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.
Laborértékek
- 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
Egyéb
- 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.
A regiszterben nem jelölt feltételek
- 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
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.