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

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: INV-347

Study type: Interventional

Funder types: Industry

Identifiers

NCT07153172

U1111-1319-3945 (Other Identifier)

NN9441-8452

Details and patient eligibility

About

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.

Enrollment: 91 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Participants from the study INV-CL-108

Experimental group

Description:

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.

Treatment:

Drug: INV-347