A Study of PATAS Using Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Diabetic Subjects

NCT07223333 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PATAS-CL-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief Summary

This is 2-part study. The primary objective of Part 1 is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. Secondary objectives of Part 2 include evaluation of the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers and characterization of of adverse event (AE) profiles of the various dose levels of PATAS.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; insulin resistance

Outcome Measures

Primary Outcomes (12)

• Phase 1B: Safety

  Incidence and severity (using CTCAE version 5.0.) of treatment-emergent AEs and SAEs

  29 days

• OGTT

  Oral glucose tolerance test

  Baseline, Day 28

• Cmax

  Maximum observed plasma concentration

  Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23

• Tmax

  Time to Cmax

  Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23

• AUClast

  Area under the concentration-time curve (AUC) from time 0 to the last measurable plasma concentration

  Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23

• AUCinf

  AUC extrapolated to infinity (AUCinf);

  Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23

• T1/2

  Apparent plasma terminal elimination half-life

  Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23

• CL/F

  Apparent total plasma clearance after SC injection

  Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23

• HOMA-IR

  Homeostatic Model Assessment of Insulin Resistance

  Baseline, Day 28

• TyG

  Changes in triglyceride-glucose index

  Baseline, Day 28

• Adipo-IR

  Changes in Adipose Tissue Insulin Resistance Index

  Baseline, Day 28

• Changes in glucose and insulin levels

  Changes in glucose and insulin levels

  Baseline, Day 28

Study Arms (2)

Diabetic subjects, Placebo

PLACEBO COMPARATOR

Drug: Placebo

Diabetic Subjects, Active

EXPERIMENTAL

Drug: PATAS Trifluoroacetate

Interventions

PATAS Trifluoroacetate DRUG

A drug targeting the interaction between the ALMS1 protein and alpha-PKC

Diabetic Subjects, Active

Placebo DRUG

Excipient only formulation, without active compound

Diabetic subjects, Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF);
• Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;
• Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening;
• In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead electrocardiogram (ECG) at Screening and at Check-In (Day -1);
• Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at Check-In (Day -1) (prior to the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug;
• Negative test result for severe acute respiratory syndrome coronavirus 2 at Check-In (Day -1); and
• Willing to comply with all study procedures and requirements throughout the duration of the study.

You may not qualify if:

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• Liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], alkaline phosphatase \[ALP\], total bilirubin) outside the following upper limits of normal (ULNs) at Screening or at Check-In (Day -1): a. For ALT and AST, measurements \> ULN; b. For ALP, measurements \>ULN; or c. For total bilirubin, measurements \> ULN.
• Estimated glomerular filtration rate \</= 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening or at Check-In (Day -1);
• Thyroid-stimulating hormone (TSH) outside of reference range (e.g., TSH \<1 × lower limit of normal \[LLN\] or TSH \>1 × ULN) at Screening; Note: Abnormal TSH results will reflex to a free thyroxine (T4) test.
• History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease;
• Personal or family history of long QT syndrome;
• Abnormal pulse rate or blood pressure (BP) measurements at Screening, defined as: a. Pulse rate \<40 bpm or \>100 bpm; b. Systolic BP \< 90 mmHg or \>140 mmHg; or c. Diastolic BP \< 50 mmHg or \> 90 mmHg.
• Clinically significant ECG abnormalities at Screening or at Check-In (Day -1), defined as prolongation of the average QTcF interval \> 450 ms for males and \>470 ms for females, or other clinically significant ECG abnormalities per Investigator discretion;
• Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at Screening;
• Receipt of any investigational product within 30 days prior to first study drug administration (90 days for investigational biologic agents) or 5 half-lives prior to first study drug administration, whichever is greater, or participation in \>3 clinical studies within 12 months; 22. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol);
• Male and female subjects, 18 to 65 years of age, inclusive, at the time of signing the ICF;
• Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;
• A diagnosis of T2D \>6 months before Screening
• Subjects should be on a stable dose of
• an oral monotherapy (permitted monotherapies include metformin and dipeptidyl peptidase 4 inhibitors) for at least 90 days before Screening

Sponsors & Collaborators

• AdipoPharma LLC: lead

Study Sites (3)

Arizona Clinical Trials

Chandler, Arizona, 85225, United States

RECRUITING

Clinical Pharmacology of Miami

Miami, Florida, 33072, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Vincent Marion, Ph.D.

  AdipoPharma LLC

  STUDY CHAIR

Central Study Contacts

Tarek Hiwot, M.D.

CONTACT

44 7391 537 158; tarek.hiwot@adipopharma.us

Michael J Fare

CONTACT

203-671-4351; michael.fare@adipopharma.us

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Pharmacist
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 31, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)