CompletedPhase 1

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

Canada37 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Provision of a signed and dated informed consent form (ICF).
✓. Willing and able to comply with all study procedures for the duration of the study.
✓. Male or female, ≥18 and ≤65 years of age.
✓. Waist circumference ≥88 cm for female subjects or ≥102 cm for male subjects.
✓. Fasting triglyceride \>1.5 mmol/L for males and females.
✓. 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

✕. Female who is lactating at screening.
✕. Female who is pregnant according to a pregnancy test at screening or prior to study drug administration.
✕. History of significant hypersensitivity to the study drug or excipients of the study drug.
✕. History of severe hypersensitivity reactions, such as anaphylaxis.
✕. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
✕. Positive screening results to HIV antigen and antibody, HBsAg or HCV tests.
✕. Poses a significant suicidal risk as defined by C-SSRS score \>Type 1 ideation at screening.
✕. Any clinically significant illness in the 28 days prior to study drug administration.

What they're measuring

Number and Frequency of Adverse Events

Timeframe: 28 Days

Trial details

NCT IDNCT05282446

SponsorInversago Pharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-11

View on ClinicalTrials.gov More Metabolic Syndrome trials