Safety follow-up after INV-347 dosing in INV-CL-108

Safety Follow-up Study of Participants Previously Dosed With INV-347 in the First-in-Human Study INV-CL-108

This follow-up checks the safety and blood levels of INV-347 in adults who previously received INV-347 in INV-CL-108.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 91 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novo Nordisk A/S (industry)
• Locations: 1 site (Québec)
• Trial ID: NCT07153172 on ClinicalTrials.gov

What this trial studies

This study follows adults who were previously dosed with INV-347 in INV-CL-108 to monitor safety and measure plasma concentrations over time. No additional study drug will be given; participants will attend scheduled visits through visit 21 for blood sampling and safety assessments. To enroll, participants must be 18 or older and have a measurable INV-347 plasma concentration above the lower limit of quantification (0.5 ng/mL). The study is sponsored by Novo Nordisk and is being conducted at Syneos Health Clinique in Québec.

Who should consider this trial

Good fit: Adults (age 18+) who were previously dosed with INV-347 in INV-CL-108 and who have a measurable INV-347 plasma level above 0.5 ng/mL at enrolment are eligible.

Not a fit: People who did not receive INV-347 in INV-CL-108 or who have no measurable INV-347 in their blood are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the follow-up could improve understanding of how long INV-347 persists in the body and confirm its longer-term safety after dosing.

How similar studies have performed: Post-dosing safety and pharmacokinetic follow-ups are common and have previously informed dosing and monitoring decisions for other drugs, though INV-347-specific long-term data remain limited.

Eligibility criteria

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.

Where this trial is running

Québec

• Syneos Health Clinique — Québec, Canada (RECRUITING)

Study contacts

• Study coordinator: Novo Nordisk

Conditions: Obesity