ObesityPhase 1NCT07153172
Safety Follow-up Study of Participants Dosed With INV-347 in Study INV-CL-108
A Phase 1 study testing INV-347 in people with Obesity, run by Novo Nordisk A/S at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- INV-347
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- 6 Aug 2025to 15 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)].
Who cannot join
- The study has no exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety Follow-up Study of Participants Previously Dosed With INV-347 in the First-in-Human Study INV-CL-108
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
- Being tested
- INV-347
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-347Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: INV-347 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of events
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start6 Aug 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153172
- Sponsor's protocol ID
- NN9441-8452
- Other IDs
- U1111-1319-3945
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Follow-up Study of Participants Previously Dosed With INV-347 in the First-in-Human Study INV-CL-108
- ClinicalTrials.gov ID
- NCT07153172
- Acronym / sponsor ID
- NN9441-8452
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants from the study INV-CL-108 | Experimental | Drug: INV-347Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)].
Key exclusion criteria (1 listed)
- The study has no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INV-347Participants 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 | Participants from the study INV-CL-108 |
Primary outcome
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)
Number of events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INV-347 in people with Obesity, run by Novo Nordisk A/S at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.