Recruiting

Mirabegron & Tadalafil

Sponsor:

Philip Kern

Code:

NCT05051436

Conditions

Pre-diabetes

Obesity

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

Interventions

Mirabegron 50 MG

Tadalafil 10 MG

Placebo

Study Details

Brief summary:

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.

Conditions

Pre-diabetes

Obesity

Study ID

NCT05051436

Start date

Dec 13, 2021

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Hemoglobin A1C between 5.7 and 6.4
  • Body mass index between 27 and 45

Exclusion Criteria:

  • Diabetes
  • Chronic use of any antidiabetic medications
  • Any unstable medical condition
  • Use of steroids or daily use of NSAIDS
  • History of chronic inflammatory conditions
  • Use of anticoagulants
  • Contraindications to the use of mirabegron or tadalafil
  • Any condition deemed risky by the study physician

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mirabegron (M)

Drug will be administered for 12 weeks after baseline procedures.

experimental: Tadalafil (T)

Drug will be administered for 12 weeks after baseline procedures.

experimental: Mirabegron and Tadalafil (MT)

Both drugs will be administered for 12 weeks after baseline procedures.

placebo comparator: Placebo (P)

Interventions

Mirabegron 50 MG

Mirabegron 50 mg/day will be administered for 14 weeks.

Tadalafil 10 MG

Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.

Placebo

Placebo will be administered for 14 weeks after baseline procedures.

Primary outcome measure

  • Oral glucose tolerance test [ Time Frame: Baseline ]
  • Oral glucose tolerance test [ Time Frame: 14 weeks ]

Central Contacts and Locations

Central contacts

Zach Leicht

859-218-1397zachary.leicht@uky.edu

Philip Kern, M.D.

859-218-1394pake222@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Zach Leicht

859-218-1397zachary.leicht@uky.edu

Principal Investigator:

Philip Kern, M.D.

More Information

Sponsor

Philip Kern

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Tadalafil
  • Mirabegron

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Philip Kern on 2026-08-31.