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NCT05051436RecruitingPhase 4

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Source: ClinicalTrials.gov · Last updated 31 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
96 (estimated)
First submitted
10 Sept 2021
Start date
Dec 2021
Primary completion date
Jan 2027
Lead sponsor
Philip Kern
Diseases
Obesity
NCT number
NCT05051436

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 96
  • From Dec 2021 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chronic use of any antidiabetic medications
  • Use of steroids or daily use of NSAIDS

Other illness

  • Diabetes
  • Any unstable medical condition
  • History of chronic inflammatory conditions
  • Any condition deemed risky by the study physician

Other

  • Use of anticoagulants
  • Contraindications to the use of mirabegron or tadalafil

Who the study is looking for

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

Age in the registry: 35 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.