Mirabegron 50 MG for Obesity

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Obesity+2 More
Mirabegron 50 MG - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

3 of 3
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

3 of 3
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: Drug
Tadalafil (T)
Drug
Experimental Group · 1 Intervention: Tadalafil 10 MG · Intervention Types: Drug
Placebo (P)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
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 preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

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?
Kentucky100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Kentucky100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%