Vancomycin for Obesity

Overseen By Amit Pai, PharmD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Michigan

Must not be taking: GLP1 agonists, Ototoxic drugs

Disqualifiers: Pregnancy, Allergies, Cardiovascular, Renal, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes participants taking ototoxic drugs (medications that can damage hearing). It's best to discuss your current medications with the trial team.

How does the drug Vancomycin differ from other obesity treatments?

Vancomycin is unique in obesity treatment as it is primarily an antibiotic used to treat infections, unlike typical anti-obesity drugs that focus on weight loss through appetite suppression or fat absorption inhibition. This novel approach may involve altering gut bacteria, which is not a standard mechanism in current obesity treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this clinical trial is to learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. The main questions it aims to answer are: Does dosing vancomycin based on kidney function provide better drug exposure than dosing based on weight? What medical or safety issues arise when vancomycin is dosed according to weight versus kidney function? Participants will be randomized into two groups. One group will receive vancomycin doses based on their weight, while the other will receive doses based on their kidney function. Participants will: Receive a single dose of vancomycin based on either their weight or kidney function after pretreatment with antihistamines Provide blood and urine samples at specific times for pharmacokinetic analysis Undergo body composition measurements using DEXA scans and other methods Visit the clinic for physical exams, medical history, and laboratory tests

Eligibility Criteria

This trial is for obese adults who need vancomycin treatment. Participants must be willing to provide blood and urine samples, undergo body composition measurements, and attend clinic visits for exams and tests.

Inclusion Criteria

I am obese, with a BMI in one of the specified ranges.

I weigh 80 kg or more.

My kidney function, measured by creatinine clearance, is within the required range.

Exclusion Criteria

History of severe allergic diseases including drug allergies, with the exception of seasonal allergies

Participants with underlying hearing loss

Pregnant or lactating females

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of vancomycin based on either their weight or kidney function, with blood and urine samples collected for pharmacokinetic analysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including body composition measurements and laboratory evaluations

1-2 weeks

Treatment Details

Interventions

• Vancomycin

Trial Overview The study is testing how best to dose vancomycin in obese individuals by comparing two methods: one based on the patient's weight and the other on kidney function. It aims to determine which method provides better drug exposure.

Participant Groups

Group I: Test Experimental Treatment 1 Intervention

Kidney function stratified dosing

Group II: Control Active Control 1 Intervention

Weight-stratified dosing as the current standard of care

Vancomycin is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Vancocin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus
• Staphylococcal endocarditis

Approved in European Union as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis
• Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD)

Approved in Canada as Vancomycin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus

Approved in Japan as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

Obesity is linked to serious health risks, including coronary heart disease and premature death, independent of traditional risk factors, highlighting the need for comprehensive evaluation and treatment strategies.

Effective treatment for obesity should focus on moderate caloric reduction, improved eating habits, and increased physical activity, with group therapy showing promising results; very hypocaloric diets can also improve mood and reduce sleep needs in severely obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation and treatment of obesity in clinical practice]. Keller, U., van der Werf, H., Stohler, R.[2012]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Drug therapy of obesity. Strategies for general practice]. [2018]

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

Case Report: Bilateral Ciliary Body Detachment in a Patient Taking Oral Diet Pills. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fenproporex for obesity treatment: a systematic review. [2018]

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

Medications Available for Weight Reduction in Elective Total Joint Arthroplasty. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Evaluation and treatment of obesity in clinical practice]. [2012]