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

NCT05282446 | Completed Phase 1

• 1 other identifier: INV-202 CL-105
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Number and Frequency of Adverse Events

  Safety and Tolerability as assessed by Adverse Events

  28 Days

Secondary Outcomes (1)

• Pharmacokinetic profile of INV-202

  28 Days

Study Arms (2)

INV-202

EXPERIMENTAL

INV-202 25mg by mouth once daily

Drug: INV-202

Placebo

PLACEBO COMPARATOR

Matching placebo by mouth once daily

Drug: Placebo

Interventions

INV-202 DRUG

tablet

INV-202

Placebo DRUG

matching tablet

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:

• 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%.

You may not qualify if:

• 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.
• Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability.
• History of significant and uncontrolled or unstable cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
• History of seizures (epilepsy) of any kind.
• History of cranial surgery.
• Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum Fridericia's corrected QT interval \[QTcF\] 450 msec).
• 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).
• 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):

Sponsors & Collaborators

• Inversago Pharma Inc.: lead

Study Sites (1)

Syneos Health Clinique Inc

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 16, 2022
• Study Start: March 1, 2022
• Primary Completion: September 11, 2022
• Study Completion: October 1, 2022
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)