A Study to Explore the PK and PD of INV-202 in Metabolic Syndrome

• ClinicalTrials.gov Identifier: NCT05282446
• Recruitment Status: Completed
• First Posted: March 16, 2022
• Last Update Posted: October 5, 2022
• Sponsor: Inversago Pharma Inc.
• Information provided by (Responsible Party): Inversago Pharma Inc.

Tracking Information

• First Submitted Date: February 16, 2022
• First Posted Date: March 16, 2022
• Last Update Posted Date: October 5, 2022
• Actual Study Start Date: March 1, 2022
• Actual Primary Completion Date: September 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 4, 2022)

Number and Frequency of Adverse Events [ Time Frame: 28 Days ]

Safety and Tolerability as assessed by Adverse Events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 4, 2022)

Pharmacokinetic profile of INV-202 [ Time Frame: 28 Days ]

Pharmacokinetic profile of INV-202 in blood. Minimum concentration in blood after 1,2,3,and 4 weeks of dosing.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Explore the PK and PD of INV-202 in Metabolic Syndrome
• Official Title: A Phase 1B Study to Examine the Pharmacokinetic and Pharmacodynamic Effects of INV-202 in Subjects With Metabolic Syndrome as Defined by Hypertriglyceridemia, Abdominal Obesity, and Impaired Glucose Tolerance Over 28 Days.
• Brief Summary: INV-202-CL-105 is a phase 1B study to examine the safety and tolerability, as well as the pharmacokinetics (PK) pharmacodynamic (PD) effects of INV-202 in subjects with metabolic syndrome over 28 days.

Detailed Description

INV-202-CL-105 is a phase 1B study to examine the safety and tolerability, as well as the pharmacokinetics (PK) pharmacodynamic (PD) effects of INV-202 in subjects with metabolic syndrome over 28 days.

Subjects with metabolic syndrome as defined as an increased waist circumference, hypertriglyceridemia, and glucose intolerance will be randomized to INV-202 or placebo for 28 to assess PK/PD relationships and other biomarkers.

• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Double blinded

Primary Purpose: Treatment

• Condition: Metabolic Syndrome

Intervention

• Drug: INV-202
  tablet
• Drug: Placebo
  matching tablet

Study Arms

• Experimental: INV-202
  INV-202 25mg by mouth once daily
  Intervention: Drug: INV-202
• Placebo Comparator: Placebo
  Matching placebo by mouth once daily
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2022): 37
• Original Estimated Enrollment (submitted: March 4, 2022): 40
• Actual Study Completion Date: October 1, 2022
• Actual Primary Completion Date: September 11, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Provision of a signed and dated informed consent form (ICF).
2. Willing and able to comply with all study procedures for the duration of the study.
3. Male or female, ≥18 and ≤65 years of age.
4. Waist circumference ≥88 cm for female subjects or ≥102 cm for male subjects.
5. Fasting triglyceride >1.5 mmol/L for males and females.
6. An OGTT indicating impaired glucose tolerance as indicated by a 2-hour value >140 mg/dl or any value >200 mg/dl at any time point or a HbA1C level ≥5.7% but ≤6.4%.

Exclusion Criteria:

1. Female who is lactating at screening.
2. Female who is pregnant according to a pregnancy test at screening or prior to study drug administration.
3. History of significant hypersensitivity to the study drug or excipients of the study drug.
4. History of severe hypersensitivity reactions, such as anaphylaxis.
5. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
6. Positive screening results to HIV antigen and antibody, HBsAg or HCV tests.
7. Poses a significant suicidal risk as defined by C-SSRS score >Type 1 ideation at screening.
8. Any clinically significant illness in the 28 days prior to study drug administration.
9. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability.
10. History of significant and uncontrolled or unstable cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
11. History of seizures (epilepsy) of any kind.
12. History of cranial surgery.
13. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum Fridericia's corrected QT interval [QTcF] 450 msec).
14. Any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of an investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data. Mild elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) as may be seen in non-alcoholic fatty liver disease (NAFLD) are not exclusionary. However, in these subjects, please follow the hepatic safety section.
15. New prescription medication or changes to medication regimen within 90 days prior to the first dose. (i.e., stable doses of anti-hypertensives etc. are allowed).

16. Use of the following medications for the time frames specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):

    1. Any vaccination, including COVID-19 vaccine, within 14 days prior to the first dose;
    2. Depot injection or implant of any drug within 3 months prior to the first dose;
    3. Any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first dose.
    4. Any drugs for the treatment of diabetes within 30 days prior to the first dose.
    5. Any drugs prohibited by the Investigator on a case-by-case basis because they are judged likely to affect the PD profile of the study drug or subject safety, within at least 5 times the half-life of the drug and a minimum of 30 days prior to the first dose.
17. Positive urine drug screen or alcohol breath test at screening.
18. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
19. History of significant drug abuse within 1 year prior to screening, use of soft drugs within 3 months prior to screening, marijuana within 1 month prior to screening, or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
20. Use of any cannabinoid containing product, including cannabis, within 1 month prior to screening, by any route (e.g., oral, inhaled, topical).
21. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or a minimum of 5 half-lives, whichever is longer) prior to the first dose, administration of a biological product in the context of a clinical research study within 90 days prior to the first dose, or concomitant participation in an investigational study involving no drug or device administration.
22. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dose.
23. Any reason, which in the opinion of the Investigator, would prevent the subject from participating in the study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT05282446
• Other Study ID Numbers: INV-202 CL-105
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Inversago Pharma Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Inversago Pharma Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Glenn D Crater, MD; Inversago Pharma

• PRS Account: Inversago Pharma Inc.
• Verification Date: October 2022