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Obesity, PrediabetesPhase 1NCT05634174

ADRB3 Signaling Pathway in Human Adipose Tissue

A Phase 1 study testing Mirabegron in people with Obesity, Prediabetes, run by University of California, San Diego at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will examine the gene expression of the adrenergic Beta-3 receptor (ADRB3) regulation in human subcutaneous adipose tissue before and after treatment with mirabegron, an ADRB3 agonist. Gene expression will be compared across two groups, lean and obese participants. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Prediabetes
What is being tested?
Mirabegron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Males and females 18-70 years old 4. Lean participants, defined as:
  • BMI <27 kg/m2
  • Normal glucose tolerance defined as fasting glucose less than 100 mg/dL or HbA1c of less than 5.7% at the time of the screening visit 5. Obese Insulin resistant participants, defined as:
  • BMI 30-40 kg/m2
  • Prediabetes defined as fasting glucose levels of 100 to 125 mg/dL or HbA1c of 5.7% to 6.4%
  • Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Who cannot join

  • 1. Diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis of diabetes 2. Pregnancy or lactation 3. Currently taking therapeutic anticoagulation which might increase risk of bleeding from fat biopsy (e.g., warfarin, direct oral anticoagulants) 4. History of eating disorder 5. Currently enrolled in a weight-loss or weight-management program 6. On a special or prescribed diet for other reasons (e.g., Celiac disease) 7. Currently taking any medication that is meant for, or has known effect on, appetite 8. Any history of surgical intervention for weight management 9. Abnormal screening labs (renal dysfunction (eGFR < 30 ml/min/1.73 m2), anemia, hypo- or hyperthyroidism, coagulopathy, abnormal liver function (AST, ALT > 3x upper limit of normal) 10. Local or systemic infectious disease with fever or requiring antibiotic within four weeks of screening visit 11. QTc interval above normal or the current use of any concomitant QT-prolonging drug 12. A clinically significant abnormal ECG 13. Current addiction to alcohol or substances of abuse 14. Unwillingness or language barriers precluding adequate understanding or cooperation 15. Use of systemic corticosteroids or other medication known to cause insulin resistance in previous six weeks prior to the screening visit and throughout the study 16. Diagnosis of bladder outlet obstruction or use of antimuscarinic medications for treatment of overactive bladder 17. Use of β-adrenergic receptor blockers or calcium channel blockers 18. Heart disease including Coronary Artery Disease (CAD), Congestive Heart Failure (CHF), or cardiac arrhythmias 19. Uncontrolled sever hypertension (Defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥110 mm Hg) 20. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC San Diego Altman Clinical & Translational Research Institute

    La Jolla, California, 92037

Other trials in United States

About this study

Official title: Identifying Responsible Signaling Pathway for Adrenergic Beta-3 Receptor Regulation in Human Subcutaneous White Adipose Tissue

This study will examine the gene expression of the adrenergic Beta-3 receptor (ADRB3) regulation in human subcutaneous adipose tissue before and after treatment with mirabegron, an ADRB3 agonist. Gene expression will be compared across two groups, lean and obese participants. There will be a total of three study visits: Screening/Eligibility, Pre-Dose Adipose Tissue Biopsy and Post-Dose Adipose Tissue Biopsy. Participants will be given a single dose of 100mg oral mirabegron on the day of the Post-Dose Adipose Tissue Biopsy.The trial design is a single-center, phase 1, open-label, exploratory study to examine the adipocyte gene expression in adults treated with 1 dose of 100mg oral mirabegron.

Read the detailed description

The trial design is a single-center, phase 1, open-label, exploratory study to examine the adipocyte gene expression in adults treated with 1 dose of 100mg oral mirabegron.

This is an exploratory study to examine the effects of a single dose of mirabegron on adipocytes in insulin resistant obese individuals and lean controls. Approximately 40 patients over the age of 18 will be recruited for the study (20 obese individuals with insulin resistance and 20 lean controls).

There will be a total of three study visits: Screening/Eligibility, Pre-Dose Adipose Tissue Biopsy and Post-Dose Adipose Tissue Biopsy. All visits will take place at the ACTRI research clinic at UC San Diego. The Screening/Eligibility visit will involve collection of safety data and eligibility criteria, medical/medication history, physical exam, vitals, ECG and collection of urine and blood for safety laboratory analysis. The procedures completed at the Pre-Dose visit will be, vitals, re-review of medical history and changes since last visit, indirect calorimetry, an oral glucose tolerance test (OGTT), an adipose tissue biopsy, blood sample collection and study drug dispensing (one dose to be taken the morning of the following visit). The procedures completed at the Post-Dosing visit will be identical to those completed at the Baseline visit, except there will not be an OGTT at the Post-Dosing Visit.

Being tested
Mirabegron
Medical subject headings
Obesity, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirabegronDrug

    Also called Myrbetriq

    Single dose, 100mg oral mirabegron

Study groups in NCT05634174
Study groupRoleWhat they receive
Obese GroupExperimentalSingle dose, 100mg oral mirabegron in Obese Insulin Resistant adults
Receives: Drug: Mirabegron
Non-Obese GroupExperimentalSingle dose, 100mg oral mirabegron in Non-Obese adults
Receives: Drug: Mirabegron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ADRB3 gene expression

    The change from baseline in ADRB3 gene expression as measured by qPCR

    Measured: 28 days (± 14 days)

  2. ADRB3 protein levels

    The change from baseline in ADRB3 protein levels as measured by Western Blot

    Measured: 28 days (± 14 days)

  3. Glycerol Measured Catecholamine Sensitivity

    The change from baseline in catecholamine sensitivity as measured by glycerol from adipose tissue lipolysis

    Measured: 28 days (± 14 days)

  4. Free Fatty Acid measured Catecholamine Sensitivity

    The change from baseline in catecholamine sensitivity as measured by Free Fatty Acid from adipose tissue lipolysis

    Measured: 28 days (± 14 days)

Secondary outcomes (2)

  1. FGF-21 Adipokine Gene Expression

    The change from baseline in FGF-21 gene expression as measured by qPCR

    Measured: 28 days (± 14 days)

  2. IL-6 Adipokine Gene Expression

    The change from baseline in IL-6 gene expression as measured by qPCR

    Measured: 28 days (± 14 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start1 Aug 2023
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634174
Sponsor's protocol ID
UC-MEDVH-01
Status last verified
Oct 2024
First submitted
21 Nov 2022
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mirabegron in people with Obesity, Prediabetes, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADRB3 gene expression (time frame: 28 days (± 14 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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