NCT05051436

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
2mo left

Started Dec 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2021Aug 2026

First Submitted

Initial submission to the registry

September 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4.6 years

First QC Date

September 10, 2021

Last Update Submit

February 2, 2026

Conditions

Pre-diabetesObesity

Keywords

TadalafilMirabegron

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    14 weeks

Secondary Outcomes (2)

  • Hemoglobin A1C

    Baseline

  • Hemoglobin A1C

    14 weeks

Other Outcomes (4)

  • Fat biopsy

    Baseline

  • Fat biopsy

    14 weeks

  • Muscle biopsy

    Baseline

  • +1 more other outcomes

Study Arms (4)

Mirabegron (M)

EXPERIMENTAL

Drug will be administered for 12 weeks after baseline procedures.

Drug: Mirabegron 50 MG

Tadalafil (T)

EXPERIMENTAL

Drug will be administered for 12 weeks after baseline procedures.

Drug: Tadalafil 10 MG

Mirabegron and Tadalafil (MT)

EXPERIMENTAL

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

Drug: Mirabegron 50 MGDrug: Tadalafil 10 MG

Placebo (P)

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Mirabegron 50 MGDRUG

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

Mirabegron (M)Mirabegron and Tadalafil (MT)
Tadalafil 10 MGDRUG

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

Mirabegron and Tadalafil (MT)Tadalafil (T)
PlaceboDRUG

Placebo will be administered for 14 weeks after baseline procedures.

Placebo (P)

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Glucose IntoleranceObesity

Interventions

mirabegronTadalafil

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Philip Kern, M.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zach Leicht

CONTACT

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

Philip Kern, M.D.

CONTACT

859-218-1394pake222@uky.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 21, 2021

Study Start

December 13, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)