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Metabolic SyndromePhase 1NCT05282446

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

A Phase 1 study testing INV-202 in people with Metabolic Syndrome, run by Inversago Pharma Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
INV-202
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteCanada
Study dates
1 Mar 2022to 1 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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).
  • 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.
  • 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):
  • Any vaccination, including COVID-19 vaccine, within 14 days prior to the first dose;
  • Depot injection or implant of any drug within 3 months prior to the first dose;
  • Any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first dose.
  • Any drugs for the treatment of diabetes within 30 days prior to the first dose.
  • 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.
  • Positive urine drug screen or alcohol breath test at screening.
  • 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]).
  • 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.
  • Use of any cannabinoid containing product, including cannabis, within 1 month prior to screening, by any route (e.g., oral, inhaled, topical).
  • 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.
  • 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.
  • Any reason, which in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Syneos Health Clinique Inc

    Québec, Quebec, G1P 0A2

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
INV-202, Placebo
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INV-202Drug

    tablet

  • PlaceboDrug

    matching tablet

Study groups in NCT05282446
Study groupRoleWhat they receive
INV-202ExperimentalINV-202 25mg by mouth once daily
Receives: Drug: INV-202
PlaceboPlacebo comparatorMatching placebo by mouth once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Frequency of Adverse Events

    Safety and Tolerability as assessed by Adverse Events

    Measured: 28 Days

Secondary outcomes (1)

  1. 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.

    Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start1 Mar 2022
  3. Primary completion11 Sep 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05282446
Sponsor's protocol ID
INV-202 CL-105
Status last verified
Mar 2025
First submitted
16 Feb 2022
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INV-202 in people with Metabolic Syndrome, run by Inversago Pharma Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Frequency of Adverse Events (time frame: 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05282446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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