91 Participants Needed

INV-347 for Obesity

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety of a drug called INV-347, previously tested for obesity treatment. Participants will not receive the drug again; instead, researchers will monitor how their bodies continue to process it over time. The study targets individuals who participated in a past trial and still have detectable levels of INV-347 in their blood. As a Phase 1 trial, the research focuses on understanding how the treatment functions in people, providing valuable insights into its long-term effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Is there any evidence suggesting that INV-347 is likely to be safe for humans?

Research shows that INV-347 is in the early stages of human testing, meaning complete safety information is not yet available. These early tests primarily focus on safety, with researchers closely monitoring INV-347 for any side effects. Since participants have already taken the drug, researchers are particularly interested in any long-term safety issues.

As INV-347 remains in the early testing phase, its safety is under careful study. So far, no clear reports of serious side effects have emerged. Participants should understand that the main goal is to gather as much safety information as possible.12345

Why are researchers excited about this trial?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or even surgical options, INV-347 is unique because it is designed to assess long-term safety after initial human exposure. Researchers are excited about INV-347 because it may offer a novel approach by maintaining measurable plasma exposure over time, which could potentially lead to sustained effects in managing obesity. This ongoing exposure might help in understanding the long-term impact and safety of the treatment, which is a crucial consideration for chronic conditions like obesity.

What evidence suggests that INV-347 might be an effective treatment for obesity?

Research has shown that INV-347 led to significant weight loss in earlier studies, with noticeable results in just 28 days. This drug blocks a specific receptor in the brain, helping to reduce appetite and support weight loss. Some participants reported mild to moderate side effects, such as anxiety. Although Novo Nordisk decided not to continue developing INV-347, the initial results for weight loss were promising. Those interested in this treatment should consider the potential benefits and possible side effects.26789

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for individuals who were previously given the drug INV-347 in an earlier study (INV-CL-108) and are being monitored for safety. The focus is on those with obesity, but no new participants will be dosed.

Inclusion Criteria

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
I am either male or female by birth.
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)]
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Exclusion Criteria

The study has no exclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Follow-up

Participants are monitored for safety and blood levels of INV-347 without receiving any study drug

104 weeks

End-of-study visit

Final assessment of participants' safety and any adverse events

1 visit

What Are the Treatments Tested in This Trial?

Interventions

  • INV-347
Trial Overview The trial monitors long-term safety and blood levels of INV-347 in past participants. It's a follow-up study without additional drug administration, lasting approximately 2 years to track any delayed effects.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants from the study INV-CL-108Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

Novo Nordisk's INV-347 Safety Study: Key Insights for ...The primary objective is to assess the long-term safety and blood levels of the drug INV-347 in participants who were previously dosed in the ...
Investor presentation First three months of 2025NN9441 – INV-347. NN9542 – OW GIP/GLP-1 co-agonist. NN6535 – Oral ... outcomes data. Develop next-generation treatments. Page 60. 60. Novo ...
Novo Nordisk Completes Phase 2a Clinical Study of New ...While the drug demonstrated significant weight loss effects, the mild to moderate neuropsychiatric side effects, specifically anxiety, ...
4.inversago.cominversago.com/en/news/
News & Events-Study results demonstrated favorable safety, tolerability, and PK profile -Clinically significant weight loss was observed in only 28 days -Positive trends in ...
Novo Nordisk drops 2 obesity drugs during pipeline clearoutThe drugmaker also revealed that it has given up on INV-347, a next-generation CB1 receptor blocker acquired as part of the buyout of Inversago ...
Novo Nordisk's INV-347 Safety Study: Key Insights for ...This research is significant as it aims to ensure the safety of INV-347, which is being developed for obesity treatment. Intervention/Treatment: ...
Find a clinical trial... Long-term Effects of Semaglutide in ... Obesity A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity.
Novo Nordisk R&D Investor EventINV-347. Phase 1 ongoing. Triple (tri-agonist). Phase 1 ... • 33 million patient years of exposure of sema3 supporting long-term safety.
Clinical trial updates on INV-202 and INV-347In January 2024, Novo Nordisk initiated a phase 1 trial with a next-generation oral small molecule CB1 receptor blocker INV-347.
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