Mirabegron for Obesity

Overseen By Todd May

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Must not be taking: Anticoagulants, Appetite suppressants, Corticosteroids, others

Disqualifiers: Diabetes, Pregnancy, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking certain medications like anticoagulants, appetite-affecting drugs, systemic corticosteroids, β-adrenergic receptor blockers, or calcium channel blockers. It's best to discuss your specific medications with the trial team.

How is the drug Mirabegron unique for treating obesity?

Mirabegron is unique for treating obesity because it is primarily used for overactive bladder and works by relaxing bladder muscles, which is different from traditional obesity treatments like surgery or gastric balloons that focus on reducing stomach size or absorption. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults aged 18-70 with prediabetes and obesity (BMI 30-40) or lean individuals (BMI <27) with normal glucose levels. Participants must not be on certain heart medications, have a history of eating disorders, substance abuse, bladder issues, diabetes, heart disease or other conditions that affect study participation.

Inclusion Criteria

I am obese with prediabetes and agree to follow lifestyle guidelines during the study.

You are considered lean, meaning your body mass index is less than 27, and you have normal glucose levels.

Provision of signed and dated informed consent form

Exclusion Criteria

You are on a special diet for medical reasons like Celiac disease.

I have heart disease, such as CAD, CHF, or irregular heartbeats.

I haven't had an infection needing antibiotics or causing fever in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Dose Adipose Tissue Biopsy

Participants undergo vitals check, medical history review, indirect calorimetry, oral glucose tolerance test, adipose tissue biopsy, blood sample collection, and receive study drug for next visit

1 day

1 visit (in-person)

Post-Dose Adipose Tissue Biopsy

Participants undergo vitals check, medical history review, adipose tissue biopsy, and blood sample collection after taking the study drug

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in catecholamine sensitivity, gene expression, and protein levels

28 days (± 14 days)

Treatment Details

Interventions

• Mirabegron

Trial Overview The study tests how the gene expression in fat tissue changes after a single dose of mirabegron in lean and obese participants. It's an exploratory phase 1 trial involving three visits: screening, pre-dose biopsy, and post-dose biopsy to assess the effects on ADRB3 signaling pathways.

Participant Groups

Group I: Obese Group Experimental Treatment 1 Intervention

Single dose, 100mg oral mirabegron in Obese Insulin Resistant adults

Group II: Non-Obese Group Experimental Treatment 1 Intervention

Single dose, 100mg oral mirabegron in Non-Obese adults

Mirabegron is already approved in United States, European Union for the following indications:

Approved in United States as Myrbetriq for:

• Overactive bladder (OAB)
• Neurogenic detrusor overactivity (NDO)

Approved in European Union as Mirabegron for:

• Overactive bladder (OAB)
• Neurogenic detrusor overactivity (NDO)

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

References

1. Italy pubmed.ncbi.nlm.nih.gov

Gastric Bypass after multiple restrictive procedures: Roux-en-Y or One Anastomosis? A retrospective multicentric study. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

[The BIB intragastric balloon]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of the application of the intragastric balloon together with sibutramine: a prospective clinical study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Bio-enteric intragastric balloon in obese patients: a retrospective analysis of King Faisal Specialist Hospital experience. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Complications and outcome after laparoscopic bariatric surgery: LAGB versus LRYGB. [2021]