Inno8 for Hemophilia

(VOYAGER2 Trial)

Recruiting at 17 trial locations

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Disqualifiers: Prophylactic treatment, BMI ≥30, Thrombosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new medicine called Inno8 to determine its safety for people with hemophilia A, a condition where blood doesn't clot normally. Researchers will administer different doses of Inno8 to participants to understand its effects in their bodies over approximately 11 weeks. Men with hemophilia A, characterized by low factor VIII activity (a protein that helps blood clot), who have not recently received preventive treatments, might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had any prophylactic treatment for hemophilia A recently. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Inno8 is likely to be safe for humans?

Research has shown that the safety of Inno8 remains under investigation. Earlier research with healthy men aimed to demonstrate Inno8's safety. This type of study helps determine its safe use in people with hemophilia A. So far, researchers have focused on identifying any side effects from the treatment.

In studies where multiple doses of Inno8 were given to patients with hemophilia A, researchers primarily looked for unexpected medical problems following the medication. While these findings are important, the current study is in its early phase, providing less information on safety in people with hemophilia A compared to later phases. This phase mainly seeks to understand how well people tolerate the treatment and what side effects might occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hemophilia?

Unlike the standard treatments for hemophilia, which often rely on intravenous infusions of clotting factors, Inno8 stands out because it is administered orally. This new approach can significantly improve convenience and quality of life for patients who currently endure frequent injections. Researchers are excited because Inno8, with its oral dosing, could potentially enhance patient compliance and provide a more consistent therapeutic effect, reducing bleeding episodes more effectively.

What evidence suggests that Inno8 might be an effective treatment for hemophilia A?

Research has shown that Inno8 is being developed as a potential treatment for Hemophilia A. This medicine aims to improve blood clotting in individuals with this condition. Although detailed information from human studies remains limited, early research in healthy men has demonstrated that Inno8 is generally safe, which is encouraging for further testing. In this trial, participants in both Cohort 1 and Cohort 2 will receive an oral dose of NNC0442-0344 A, the investigational form of Inno8. The goal is to determine if Inno8 can safely help people with Hemophilia A manage their bleeding issues more effectively. Initial results are promising, but additional studies are needed to confirm its effectiveness for this group. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for individuals with Hemophilia A. Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis and be in stable health to participate.

Inclusion Criteria

I am between 18 and 64 years old.

I weigh at least 45 kilograms.

I have severe haemophilia A with very low factor VIII activity.

Exclusion Criteria

Body mass index ≥30.0 kilogram per square meter

I have not taken any preventive haemophilia A treatment recently.

I or my close family have had blood clots without a clear cause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive multiple ascending oral doses of Inno8

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inno8

Trial Overview The study is testing how the body reacts to different doses of a new medication called Inno8, which is intended for people with Hemophilia A. The goal is to determine the safety and appropriate dosing of Inno8 over an approximately 11-week period.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

Participants will receive oral dose of NNC0442-0344 A.

Group II: Cohort 1 Experimental Treatment 1 Intervention

Participants will receive oral dose of NNC0442-0344 A.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06649630

Study: Inno8 Medicine Doses in Healthy Men The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07220564

NCT07220564 | A Research Study Looking at How ... This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is ...

3. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN7442-7582.html

Study: How Different Doses of Study Medicine (Inno8) Work The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/NVO/pressreleases/35744963/novo-nordisks-new-study-on-haemophilia-a-treatment-what-investors-need-to-know/

Novo Nordisk's New Study on Haemophilia A Treatment ' The study aims to evaluate the safety and effectiveness of Inno8, a new drug for treating Haemophilia A, over an 11-week period. This research ...

5. withpower.com withpower.com/trial/phase-1-hemophilia-a-9-2025-ff5cc

Inno8 for Hemophilia · Info for Participants This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if ...

6. rarediseaseadvisor.com rarediseaseadvisor.com/news/study-multiple-ascending-doses-inno8-hemophilia-a/

Multiple Doses of Inno8 in Patients With Hemophilia A The primary outcome measure will be the number of treatment-emergent adverse events from day 1 (first dose) to day 46 (end of the follow-up).

7. sciencehub.novonordisk.com sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/bic2025/jan-astermark/documents/bic-2025-oral-factor.pdf

Oral factor VIII (FVIII) bispecific molecule for haemophilia A • The data on Inno8 was kindly provided by Novo Nordisk A/S,. Bagsværd, Denmark and discussed with Jacob Lund and. Damaris Bausch-Fluck.