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

Phase 1RecruitingNCT07153172

Novo Nordisk A/S91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

INV-347DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \[above lower limit of qualification (LLOQ) of 0.5 nanogram per milliliter (ng/mL)\]. Exclusion Criteria: The study has no exclusion criteria.

Locations (1)

Syneos Health Clinique

Québec, Canada

RECRUITING

Outcomes

Primary Outcomes

Number of adverse events

Number of 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)

Central Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com

Data from ClinicalTrials.gov

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