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NCT Number: NCT07153172

Safety Follow-up Study of Participants Dosed With INV-347 in Study INV-CL-108

The study looks at the safety and blood levels of the study drug INV-347 in participants who were previously dosed with INV-347 in study INV-CL-108. Participants will not get any study drug in this study as it looks into the safety of a drug previously dosed. The study will last until visit 21.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Syneos Health Clinique

Québec, G1P 0A2, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • Previously dosed with INV-347 in study INV-CL-108 and with measurable INV-347 concentration in plasma at enrolment [above lower limit of qualification (LLOQ) of 0.5 nanogram per milliliter (ng/mL)].

Exclusion criteria

The study has no exclusion criteria.

Treatment and study plan

INV-347

Drug

Participants who were dosed with INV-347 in the First In Human study INV-CL-108 and still have measurable plasma exposure of INV-347 are included to assess long term safety.

Primary outcomes

  1. Number of adverse events

    Time frame: From the end-of-study participation in INV-CL-108 (week 0) to completion of the end-of-study visit (up to week 104 from enrolment)

    Number of events

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety Follow-up Study of Participants Previously Dosed With INV-347 in the First-in-Human Study INV-CL-108

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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