PATAS for Type 2 Diabetes

Overseen By Michael J Fare

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AdipoPharma LLC

Must be taking: Metformin, DPP-4 inhibitors

Must not be taking: Insulin, Sulfonylureas

Disqualifiers: Uncontrolled diabetes, Heart disease, Cancer, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PATAS (PATAS Trifluoroacetate) to assess its safety and behavior in the body. The study consists of two parts: one for healthy individuals and another for those with Type 2 Diabetes (T2D). Individuals who have had T2D for over a year and manage it with diet, exercise, or certain medications might qualify. The trial aims to understand how PATAS affects blood sugar and its side effects. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the unique opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

If you are taking metformin or dipeptidyl peptidase 4 inhibitors, you can continue as long as you've been on a stable dose for at least 90 days before the trial. However, you must stop using insulin, sulfonylureas, and certain other diabetes medications 90 days before the trial.

Is there any evidence suggesting that PATAS Trifluoroacetate is likely to be safe for humans?

Research shows that PATAS Trifluoroacetate remains in the early testing stages, meaning its safety is still under evaluation. The current trial is a Phase 1 study, the first step in testing a treatment in people. This phase focuses on safety and how well participants can handle the treatment. Due to its early stage, limited information exists about side effects or tolerance.

However, Phase 1 trials undergo careful monitoring. Participants receive close observation for any side effects, helping researchers understand how the treatment works in the body and assess its safety for future testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Unlike the standard treatments for Type 2 Diabetes, such as metformin and insulin, PATAS Trifluoroacetate is being explored for its unique mechanism of action. Researchers are excited because it targets a novel pathway that could improve glucose regulation more efficiently. Additionally, PATAS Trifluoroacetate may offer greater safety and tolerability, which could enhance patient adherence and improve overall outcomes.

What evidence suggests that PATAS might be an effective treatment for Type 2 Diabetes?

Research has shown that PATAS Trifluoroacetate might help manage Type 2 Diabetes (T2D). Early results suggest it could effectively improve blood sugar control. The treatment may reduce insulin resistance, a primary issue in T2D. Initial data also indicates that side effects for patients with T2D are manageable, potentially balancing blood sugar without causing many unwanted effects. Although more studies are needed, early signs are promising. Participants in this trial will be divided into groups, with some receiving PATAS Trifluoroacetate and others receiving a placebo, to further evaluate its effectiveness and safety. ^{1 2 6 7 8}

Who Is on the Research Team?

Vincent Marion, Ph.D.

Principal Investigator

AdipoPharma LLC

Are You a Good Fit for This Trial?

Healthy volunteers and individuals with Type 2 Diabetes (T2D) can join this trial. Part 1 is for healthy people to test safety and how the body processes PATAS Trifluoroacetate after one dose. Part 2 is for those with T2D to assess safety over four weekly doses, its effects on blood sugar control, and overall health changes.

Inclusion Criteria

I am 18-55, healthy, with a BMI of 20-35, not pregnant, COVID-19 negative, and willing to follow study rules.

I am 18-65, with Type 2 Diabetes for over a year, managing it with diet/exercise or stable medication, have an HbA1c between 7.5% and 9.5%, a BMI of 25-40, in good health, and not pregnant.

Exclusion Criteria

Multiple Ascending Dose: Poorly controlled diabetes, history of diabetic complications, unwillingness to use study-provided continuous glucose monitor, abnormal liver function tests, abnormal thyroid-stimulating hormone, uncontrolled thyroid disorders, low estimated glomerular filtration rate, history of cardiac issues, abnormal ECG, recent use of certain medications, positive for hepatitis B, HIV, or hepatitis C, substance abuse, tobacco/nicotine use, excessive alcohol consumption

I don't have severe allergies, liver, kidney, thyroid problems, heart issues, or infectious diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Single subcutaneous doses of PATAS administered to healthy subjects to evaluate safety, tolerability, and pharmacokinetics

29 days

Treatment Part 2

Four weekly subcutaneous doses of PATAS administered to subjects with Type 2 Diabetes to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PATAS Trifluoroacetate

Trial Overview The study tests a new medication called PATAS Trifluoroacetate against a placebo. The first part involves single doses in healthy participants; the second part includes multiple doses in T2D patients, monitoring their glucose levels, insulin levels, and other health markers.

How Is the Trial Designed?

Group I: Healthy Subjects, Active Experimental Treatment 1 Intervention

Group II: Diabetes Subjects, Active Experimental Treatment 1 Intervention

Group III: Healthy subjects, Placebo Placebo Group 1 Intervention

Group IV: Diabetes Subjects, Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

AdipoPharma LLC

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223333

A Study of PATAS Trifluoroacetate Using Single Ascending ... The primary objectives of Part 2 of this study are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; ...

2. withpower.com withpower.com/trial/phase-1-diabetes-mellitus-type-2-11-2025-c3415

PATAS for Type 2 Diabetes · Info for Participants ... Trifluoroacetate will have tolerable side effects & efficacy for patients with Type 2 Diabetes, Insulin Resistance and Type 2 Diabetes ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0029752

Type 2 Diabetes Mellitus (DBCOND0029752) ... Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea ... Outcomes in Patients With Type 2 Diabetes Mellitus, No ...

4. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00282-8/fulltext

PFAS Exposure & Type 2 Diabetes, Metabolic Dysregulation Growing evidence suggests that exposure to per- and polyfluoroalkyl substances (PFAS) are linked to an increased risk of type 2 diabetes (T2D); however, ...

5. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11240026

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9388934/

Exposure to per- and polyfluoroalkyl substances (PFAS) ... The study found that each ln(ng/ml) increase in PFOA and PFHxS was significantly associated with an increase in 2-hour glucose levels (PFOA: ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352396425002828

Exposure to per- and poly-fluoroalkyl substances in ... Exposure to PFAS mixtures may be associated with increased odds for T2D in multiethnic populations via dysregulations in amino acid and drug metabolism.

8. diabetesjournals.org diabetesjournals.org/care/article/42/9/1824/36288/Associations-of-Perfluoroalkyl-and-Polyfluoroalkyl

Associations of Perfluoroalkyl and Polyfluoroalkyl Substances ... We examine the extent to which PFASs are associated with diabetes incidence and microvascular disease. Secondarily, we tested whether a lifestyle intervention ...