Obesity
Conditions
Brief summary
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
DRUGINV-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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 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 |
Countries
Canada
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed