MetAP2 Inhibition for Aging

(BIO-AGE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth Translational Research Institute

Must not be taking: Insulin, Metformin, Anti-inflammatories, Antiplatelets

Disqualifiers: Diabetes, Hypertension, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 1

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to collect Adipose tissue from young and older individuals and gather data on the effect of methionine aminopeptidase protein (MetAP2) inhibition on that Adipose tissue in the laboratory.

Will I have to stop taking my current medications?

The trial requires that you stop taking anti-inflammatory medications 2 days before a biopsy and antiplatelet medications 7 days before a biopsy, if they cannot be safely stopped for study procedures. Other medications are not specifically mentioned, so it's best to discuss with the study team.

What data supports the effectiveness of the drug MetAP2 Inhibition for aging?

Research on drugs that target aging mechanisms, like senolytics, shows promise in reducing age-related diseases by eliminating damaged cells that accumulate with age. These drugs have shown potential in improving health and reducing disease in preclinical studies, suggesting that targeting fundamental aging processes can be effective. ^{1 2 3 4 5}

How does the MetAP2 inhibition drug for aging differ from other treatments?

MetAP2 inhibition is unique because it targets a specific enzyme involved in protein processing, which may help address aging by a different mechanism than other treatments that focus on eliminating senescent cells or modifying cellular pathways. This approach could offer a novel way to influence aging processes compared to existing therapies. ^{6 7 8 9 10}

Research Team

Lauren Sparks, PhD

Principal Investigator

Study Principal Investigator

Eligibility Criteria

This trial is for healthy young adults aged 18-30 and seniors 65 or older with a BMI ≤ 40 kg/m2, who are sedentary, weight stable, and can understand English. They must be willing to follow the study plan. People with drug/alcohol abuse history, unstable medical conditions, recent tobacco use, certain allergies or infections like HIV/Hepatitis B/C, diabetes, untreated hypertension or those on specific medications cannot join.

Inclusion Criteria

Body mass index (BMI) ≤ 40 kg/m2

Willing and able to comply with scheduled visits, laboratory tests, and other study procedures

I exercise less than 20 minutes, three times a week.

Exclusion Criteria

I have type 2 diabetes with an HbA1C level of 6.5 or higher.

Tobacco or nicotine containing product use within the past 3 months

Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Adipose tissue is collected from young and older individuals for laboratory analysis

1 week

1 visit (in-person)

Laboratory Analysis

Analysis of the effect of MetAP2 inhibition on adipose tissue in the laboratory

4 weeks

Follow-up

Participants are monitored for any post-sample collection effects

4 weeks

Treatment Details

Interventions

• MetAP2 Inhibition

Trial Overview The study aims to collect fat tissue from participants to examine how blocking a protein called MetAP2 affects it in the lab. This could help understand aging-related changes in body fat.

Participant Groups

Group I: Younger with MetAP2 inhibition Experimental Treatment 1 Intervention

Participants between 18 and 30 years old with MetAP2 inhibition in conditioned media

Group II: Older with MetAP2 inhibition Experimental Treatment 1 Intervention

Participants 65 years old with MetAP2 inhibition in conditioned media

Group III: Younger without MetAP2 inhibition Active Control 1 Intervention

Participants between 18 and 30 years old without MetAP2 inhibition in conditioned media

Group IV: Older without MetAP2 inhibition Active Control 1 Intervention

Participants 65 years old and without MetAP2 inhibition in conditioned media

Who Is Running the Clinical Trial?

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

Findings from Research

In a study of 2344 patients in Phase II trials, 22% were aged 65 or older, and while elderly patients experienced higher rates of dose delays and reductions, they did not show increased rates of severe hematological toxicity compared to younger patients.

Elderly patients did experience more severe oral toxicity and alopecia, but overall, they had similar response rates to treatment as younger patients, suggesting that age alone should not exclude them from clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Entry and evaluation of elderly patients in European Organization for Research and Treatment of Cancer (EORTC) new-drug-development studies. Monfardini, S., Sorio, R., Boes, GH., et al.[2019]

References

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

Entry and evaluation of elderly patients in European Organization for Research and Treatment of Cancer (EORTC) new-drug-development studies. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Discovery, development, and future application of senolytics: theories and predictions. [2021]

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

Targeting Cellular Senescence for Age-Related Diseases: Path to Clinical Translation. [2023]

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

Senolytic Drugs: Reducing Senescent Cell Viability to Extend Health Span. [2021]

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

Pharmaceutical Intervention of Aging. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Targeted clearance of senescent cells using an antibody-drug conjugate against a specific membrane marker. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

SIRT7-Induced PHF5A Decrotonylation Regulates Aging Progress Through Alternative Splicing-Mediated Downregulation of CDK2. [2021]

8. England pubmed.ncbi.nlm.nih.gov

SIRT2 induces the checkpoint kinase BubR1 to increase lifespan. [2021]

9. England pubmed.ncbi.nlm.nih.gov

From the divergence of senescent cell fates to mechanisms and selectivity of senolytic drugs. [2022]

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

Systemic overexpression of C-C motif chemokine ligand 2 promotes metabolic dysregulation and premature death in mice with accelerated aging. [2021]