Mirabegron 50 MG for Obesity
Phase-Based Progress Estimates
Effectiveness
Safety
Obesity+2 More
Mirabegron 50 MG - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
This trial will study if the drugs mirabegron and tadalafil can improve glucose metabolism in obese, insulin-resistant people with prediabetes.
Eligible Conditions
- Obesity
- Pre-diabetes
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 14 weeks
14 weeks
Fat biopsy
Hemoglobin A1C
Muscle biopsy
Oral glucose tolerance test
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
4 Treatment Groups
Mirabegron and Tadalafil (MT)
1 of 4
Mirabegron (M)
1 of 4
Tadalafil (T)
1 of 4
Placebo (P)
1 of 4
Experimental Treatment
Non-Treatment Group
96 Total Participants · 4 Treatment Groups
Primary Treatment: Mirabegron 50 MG · Has Placebo Group · Phase 4
Mirabegron and Tadalafil (MT)Experimental Group · 2 Interventions: Tadalafil 10 MG, Mirabegron 50 MG · Intervention Types: Drug, Drug
Mirabegron (M)
Drug
Experimental Group · 1 Intervention: Mirabegron 50 MG · Intervention Types: DrugTadalafil (T)
Drug
Experimental Group · 1 Intervention: Tadalafil 10 MG · Intervention Types: DrugPlacebo (P)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 weeks
Who is running the clinical trial?
Philip KernLead Sponsor
7 Previous Clinical Trials
354 Total Patients Enrolled
1 Trials studying Obesity
70 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,122 Previous Clinical Trials
5,053,948 Total Patients Enrolled
395 Trials studying Obesity
1,479,355 Patients Enrolled for Obesity
Philip Kern, M.D.Principal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
109 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:indicates obesity
An individual with a BMI between 27 and 45 is obese.
Hemoglobin A1C between 5.7 and 6.4 percent.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Kentucky | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Kentucky | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
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