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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: INV-202; Drug: Placebo

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
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1P 0A2
      • Syneos Health Clinique Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INV-202; INV-202 25mg by mouth once daily	Drug: INV-202; tablet
Placebo Comparator: Placebo; Matching placebo by mouth once daily	Drug: Placebo; matching tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Frequency of Adverse Events	Safety and Tolerability as assessed by Adverse Events	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile of INV-202	Pharmacokinetic profile of INV-202 in blood. Minimum concentration in blood after 1,2,3,and 4 weeks of dosing.	28 Days

Collaborators and Investigators

• Sponsor: Inversago Pharma Inc.
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 11, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: INV-202 CL-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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