A Phase 4 interventional study of Mirabegron 50 MG and Tadalafil 10 MG in Pre-diabetes and Obesity, sponsored by Philip Kern. Recruiting at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Philip Kern · Phase 4, Interventional, and Treatment
The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 96 is above the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Philip Kern is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug will be administered for 12 weeks after baseline procedures.
Drug: Mirabegron 50 MG
Drug will be administered for 12 weeks after baseline procedures.
Drug: Tadalafil 10 MG
Both drugs will be administered for 12 weeks after baseline procedures.
Drug: Mirabegron 50 MG · Drug: Tadalafil 10 MG
Drug: Placebo
Mirabegron 50 mg/day will be administered for 14 weeks.
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Placebo will be administered for 14 weeks after baseline procedures.
Oral glucose tolerance test
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.
Time frame: Baseline
Oral glucose tolerance test
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.
Time frame: 14 weeks
Hemoglobin A1C
Participant hemoglobin A1C will be evaluated at baseline.
Time frame: Baseline
Hemoglobin A1C
Participant hemoglobin A1C will be evaluated at 14 weeks.
Time frame: 14 weeks
Fat biopsy
Beiging of fat as measured in the lab by histochemistry.
Time frame: Baseline
Fat biopsy
Beiging of fat as measured in the lab by histochemistry.
Time frame: 14 weeks
Muscle biopsy
Fiber type, as measured in the lab by histochemistry.
Time frame: Baseline
Muscle biopsy
Fiber type, as measured in the lab by histochemistry.
Time frame: 14 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Jan 2027, 61 months after the start.
Of 15 phase 4 interventional studies under Glucose Intolerance, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 61 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Mirabegron · Tadalafil
Philip Kern