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

NCT ID: NCT07153172

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-06

Study Completion Date

2027-09-15

Brief Summary

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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 for about 2 years.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Participants from the study INV-CL-108

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.

Group Type EXPERIMENTAL

INV-347

Intervention Type 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.

Interventions

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INV-347

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Male or female (sex at birth).
3. Age 18 years or above at the time of signing the informed consent.
4. Previously dosed with INV-347 in study INV-CL-108 and with measurable INV-347 concentration in plasma at enrolment \[above lower limit of qualification (LLOQ) of 0.5 nanogram per milliliter (ng/mL)\].
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Syneos Health

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Novo Nordisk

Role: CONTACT

(+1) 866-867-7178

Other Identifiers

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U1111-1319-3945

Identifier Type: OTHER

Identifier Source: secondary_id

NN9441-8452

Identifier Type: -

Identifier Source: org_study_id

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