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

NCT07153172 | Recruiting Phase 1

• 2 other identifiers: NN9441-8452U1111-1319-3945
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Number of 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)

Study Arms (1)

Participants from the study INV-CL-108

EXPERIMENTAL

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.

Drug: INV-347

Interventions

INV-347 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.

Participants from the study INV-CL-108

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[above lower limit of qualification (LLOQ) of 0.5 nanogram per milliliter (ng/mL)\].

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Syneos Health Clinique

Québec, G1P 0A2, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: September 3, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)