Safety Follow-up Study of Participants Dosed With INV-347 in Study INV-CL-108
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INV-347.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety Follow-up Study of Participants Previously Dosed With INV-347 in the First-in-Human Study INV-CL-108
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.
Interventions
- Drug 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.
Primary outcome measures
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Canada · 1 center
- Syneos Health Clinique — Québec
Identifiers
NCT: NCT07153172 · NN9441-8452 · U1111-1319-3945