Recruiting

Phase 2

Observational StudyMechanisms for Activation of Beige Adipose Tissue in Humans

Sponsor:

Philip Kern

Code:

NCT04666636

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

Interventions

Placebo

Mirabegron

Mirabegron 50 MG

Mirabegron 100 mg

Study Details

Brief summary:

Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients

Conditions

PreDiabetes

Study ID

NCT04666636

Start date

Dec 7, 2020

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

BMI 27-45
prediabetes (A1c 5.7-6.4)
impaired fasting glucose or impaired glucose tolerance

Exclusion Criteria:

diabetes
chronic use of anti-diabetic medication
acute or chronic inflammatory condition
unstable medical condition
cancer
renal insufficiency
any contraindication for Mirabegron
BMI >45

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Participants in the group will receive placebo.

experimental: Mirabegron

Participants in this group will receive Mirabegron for 16 weeks.

experimental: Sub-Study: Mirabegron and the acute response to food

This sub-study will involve the recruiting of the same subjects who are eligible for this study as described above. Subjects will report to the CCTS fasting on 3 separate days. On each visit, the subject will have 5 blood draws and each blood draw will be about 8 ml, for a total of 40 ml of blood at each visit. Visit 1 will involve the participant consuming a standardized meal. At visit 2, participants will take 50mg of Mirabegron. And visit 3 will involve the participant consuming the same meal as visit 1 and also taking 50 mg of mirabegron.

experimental: Sub-Study: Mirabegron dosing and Oral Glucose Tolerance Tests (Optional)

Studies have found that larger doses of mirabegron do not elicit the same improvements in insulin sensitivity. Therefore, we aim to perform a dose-response study to gain an improved understanding of mirabegron dosing and changes in insulin sensitivity.

This sub-study will have 4 total visits. visit 1 is a baseline oral glucose tolerance test. At the end of visit 1, participants will be given 6 weeks of mirabegron (25 mg) and will take 1 pill once per day for 4-6 weeks leading up to visit 2. Visit 2 will also be a standard oral glucose tolerance test. At the end of visit 2, participants will be given 6 weeks of mirabegron (50 mg) and take 1 pill once per day for 4-6 weeks leading up to visit 3. Visit 3 will also be a standard oral glucose tolerance test. At the end of visit 3, participants will be given 6 weeks of mirabegron (10 mg) and take 1 pill once per day for 4-6 weeks. Visit 4 will be the final visit and will also be a standard oral glucose tolerance test.

Interventions

Placebo

Participants will take one pill (placebo) daily for the first week and two pills daily for the remaining 15 weeks.

Mirabegron

Participants will take one pill (50mg Mirabegron) daily for the first week. For week two, participants will take two pills (50mg and 25mg Mirabegron). Unless there are side effects, for the remaining 14 weeks participants will take two pills (50mg each) daily.

Mirabegron 50 MG

Participants will take one pill (50mg Mirabegron) daily between visit 2 and visit 3

Mirabegron 100 mg

participants will be given 6 weeks of mirabegron (25 mg) and will take 1 pill once per day for 4-6 weeks. Next participants will be given 6 weeks of mirabegron (50 mg) and take 1 pill once per day for 4-6 weeks. Last participants will be given 6 weeks of mirabegron (100 mg) and take 1 pill once per day for 4-6 weeks.

Primary outcome measure

Change in Glucose Tolerance [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]
Change in Body Composition [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]
Change in Resting Metabolic Rate [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]
Change in Brown Adipose Tissue Activity [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]
Change in Peripheral Insulin Sensitivity [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]
Change in Insulin Secretion [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]
Change in glycohemoglobin [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]
Change in Matsuda Index for Dosing Sub Study [ Time Frame: Baseline, week 6, week 12, week 18 ]
Change in bile acids/blood proteins [ Time Frame: Baseline, week 1, week 2 ]

Central Contacts and Locations

Central contacts

Zach Leicht

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

Philip Kern, MD

859-218-1394 pake222@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Zach Leicht

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

Principal Investigator:

Philip Kern, MD

More Information

Sponsor

Philip Kern

Last update posted

Jul 7, 2026

Last verified

Oct, 2025

Keywords

beige
adipose
glucose
fat
BAT
diabetes
metabolism
DEXA

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 2026-07-07.