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Healthy VolunteersPhase 2FRONTIER1NCT04204408

A Research Study Investigating Mim8 in People With Haemophilia A

A Phase 2 study testing NNC0365-3769 (Mim8) in people with Healthy Volunteers and Haemophilia A With or Without Inhibitors, run by Novo Nordisk A/S at 40 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Read more about this study

Who is it for?
Ages 12 years and older, men onlyHealthy volunteers can take part
What is being tested?
NNC0365-3769 (Mim8)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
275 participants
Where
40 sitesin 12 countries
Study dates
10 Jan 2020to 6 Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 12 years and older
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Single ascending dose part 1:
  • Male, aged 18-45 years (both inclusive) at the time of signing informed consent
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
  • Multiple ascending dose part 2:
  • Male, aged 12-64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements)
  • Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical records
Show all 9Show fewer
  • Exploratory biomarker cohort:
  • Male, aged equal to or above 12 years at the time of signing informed consent (Germany and Japan have local requirements)
  • Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical recordsv

Who cannot join

  • Part 1:
  • Factor VIII activity equal to or above 150% at screening
  • Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis
  • Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
  • Part 2:
  • Known congenital or acquired coagulation disorders other than haemophilia A
Show all 19Show fewer
  • Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
  • Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
  • Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
  • Any autoimmune disease that may increase the risk of thrombosis
  • Receipt of emicizumab or drugs with similar modes of action within 5 half-lives before trial product administration
  • Ongoing or planned immune tolerance induction therapy
  • Exploratory biomarker cohort:
  • Known congenital or acquired coagulation disorders other than haemophilia A
  • Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
  • Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
  • Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
  • Any autoimmune disease that may increase the risk of thrombosis
  • Ongoing or planned immune tolerance induction therapy

Trial locations and contacts

40 sites in 12 countries.

40 sites in 12 countries

United States15 sites

  • University Of Michigan

    Ann Arbor, Michigan, 48109

  • Children's Healthcare Atlanta

    Atlanta, Georgia, 30322

  • St. Jude Clinic Novant Health

    Charlotte, North Carolina, 28204

  • Rush University Med. Cntr

    Chicago, Illinois, 60612

  • Cincinnati Child's Hsp Med Ctr

    Cincinnati, Ohio, 45229

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Dayton Children Hemostati Ctr

    Dayton, Ohio, 45404

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Michigan State University

    East Lansing, Michigan, 48823

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027

  • Versiti, CCBD

    Milwaukee, Wisconsin, 53226

  • Vanderbilt Hemostasis Thrombosis Clinic

    Nashville, Tennessee, 37232

  • Arizona H&T Phoenix Child Hosp

    Phoenix, Arizona, 85016-7710

Other trials in United States

Japan3 sites

  • Nagoya University Hospital_Blood Transfusion

    Aichi, 466-8560

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023

Other trials in Japan

Poland3 sites

  • Szpital Uniwersytecki, Oddzial Kliniczny Hematologii

    Krakow, 30-688

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, Greater Poland Voivodeship, 60-569

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776

Other trials in Poland

Spain3 sites

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital La Fe - Hemostasia y Trombosis

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)3 sites

  • Hacettepe Üniversitesi Hastanesi- Endokrinoloji

    Ankara, 06230

  • Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji

    Edirne, 22030

  • Ege Üniversitesi Hastanesi- Hematoloji

    Izmir, 35100

Other trials in Turkey (Türkiye)

Austria2 sites

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020

  • Universitätsklinik für Innere Medizin V

    Innsbruck, A 6020

Other trials in Austria

Germany2 sites

  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

    Berlin, 10117

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249

Other trials in Germany

Italy2 sites

  • Istituto di Medicina Int. A. Bianchi Bonomi Univ. Milano

    Milan, MI, 20124

  • Policlinico Umberto I Sezione Ematologia

    Roma, 00161

Other trials in Italy

South Africa2 sites

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng, 2193

  • Pietersburg Hospital

    Polokwane, Limpopo, 0699

Other trials in South Africa

Switzerland2 sites

  • Universitätsklinik für Hämatologie

    Bern, 3010

  • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie

    Zurich, 8091

Other trials in Switzerland

United Kingdom2 sites

  • Royal Free Haemophilia Comprehensive Care Centre

    London, NW3 2QG

  • Oxford Haemophilia Comprehensive Care Center

    Oxford, OX3 7LJ

Other trials in United Kingdom

Bulgaria1 site

  • UMHAT Tsaritsa Yoanna - ISUL EAD, Pediatric clinical hematology and oncology

    Sofia, 1527

Other trials in Bulgaria

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769 (Mim8) in Healthy Subjects and in Subjects With Haemophilia A With or Without Factor VIII Inhibitors

This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector.

The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.

Being tested
NNC0365-3769 (Mim8), Placebo (Mim8)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0365-3769 (Mim8)Drug

    Mim8 administered subcutaneously (s.c., under the skin). The treatment period will consist of 12 once-weekly doses or 3 once-monthly doses

  • Placebo (Mim8)Drug

    Mim8 placebo administered subcutaneously (s.c., under the skin)

Study groups in NCT04204408
Study groupRoleWhat they receive
Single dose (part 1) Mim8ExperimentalBlinded. Single doses in healthy volunteers. Dose escalation. In each of the 6 cohorts, 6 participants will receive Mim8.
Receives: Drug: NNC0365-3769 (Mim8)
Single dose (part 1) placeboPlacebo comparatorBlinded. Single doses in healthy volunteers. In each of the 6 cohorts, 2 participants will receive placebo.
Receives: Drug: Placebo (Mim8)
Multiple dose (part 2)ExperimentalOpen-label. There will be 4 cohorts receiving once-weekly doses (part 2 cohorts 1, 2, 3 and 5) and one cohort receiving once-monthly doses (part 2 cohort 4). Participants will continue into the part 2 extension on the same treatment regimen.
Receives: Drug: NNC0365-3769 (Mim8)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of treatment emergent adverse events

    Count

    Measured: From time of dosing (Day 1) to Week 16

  2. Part 2: Number of treatment emergent adverse events

    Count

    Measured: From time of first dosing (Day 1) to Week 12

  3. Part 2, extension: Number of treatment emergent adverse events

    Count

    Measured: From Week 12 up to Week 176 (16 weeks after last dose)

Secondary outcomes (24)

  1. Part 1: Number of injection site reactions

    Count

    Measured: From time of dosing (Day 1) to Week 16

  2. Part 1: Relative change in D-dimer

    Percent

    Measured: From baseline (Day 1) to Week 16

  3. Part 1: Relative change in prothrombin fragment 1 and 2

    Percent

    Measured: From baseline (Day 1) to Week 16

  4. Part 1: Relative change in fibrinogen

    Percent

    Measured: From baseline (Day 1) to Week 16

  5. Part 1: Relative change in platelets

    Percent

    Measured: From baseline (Day 1) to Week 16

  6. Part 1: Cmax, SD: the maximum concentration of Mim8 after a single dose

    μg/mL

    Measured: From baseline (Day 1) to Week 16

  7. Part 1: AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose

    μg*day/mL

    Measured: From baseline (Day 1) to Week 16

  8. Part 1: t1/2, SD: the terminal half-life of Mim8 after a single dose

    Days

    Measured: From baseline (Day 1) to Week 16

  9. Part 1: tmax, SD: the time to maximum concentration of Mim8 after a single dose

    Days

    Measured: From baseline (Day 1) to Week 16

  10. Part 1: Change in activated partial thromboplastin time

    Seconds

    Measured: From baseline (Day 1) to Week 16

  11. Part 2 (weekly and monthly dosing): Number of injection site reactions

    Count

    Measured: From time of first dosing (Day 1) to Week 12

  12. Part 2 (weekly and monthly dosing): Occurrence of anti-Mim8 antibodies

    Count

    Measured: From baseline (Day 1) to Week 12

  13. Part 2 (weekly and monthly dosing): Relative change in D-dimer

    Percent

    Measured: From baseline (Day 1) to Week 12

  14. Part 2 (weekly and monthly dosing): Relative change in prothrombin fragment 1 and 2

    Percent

    Measured: From baseline (Day 1) to Week 12

  15. Part 2 (weekly and monthly dosing): Relative change in fibrinogen

    Percent

    Measured: From baseline (Day 1) to Week 12

  16. Part 2 (weekly and monthly dosing): Relative change in platelets

    Percent

    Measured: From baseline (Day 1) to Week 12

  17. Part 2 PK session 2 (weekly dosing): Cmax, MD: the maximum concentration of Mim8 after multiple doses

    μg/mL

    Measured: From Day 57 to Day 64

  18. Part 2 PK session 2 (weekly dosing): AUCτ, MD: the area under the Mim8 concentration-time curve in the dosing interval after multiple doses

    μg*day/mL

    Measured: From Day 57 to Day 64

  19. Part 2 PK session 2 (monthly dosing): Cmax, MD: the maximum concentration of Mim8 after multiple doses

    μg/mL

    Measured: From Day 57 to Day 85

  20. Part 2 PK session 2 (monthly dosing): AUCτ, MD: the area under the Mim8 concentration-time curve in the dosing interval after multiple doses

    μg*day/mL

    Measured: From Day 57 to Day 85

  21. Part 2 (weekly dosing): Mean of maximum thrombin generation (peak height)

    nM

    Measured: From Day 57 to Day 64

  22. Part 2 (monthly dosing): Mean of maximum thrombin generation (peak height)

    nM

    Measured: From Day 57 to Day 85

  23. Part 2, extension: Number of injection site reactions

    Count

    Measured: From Week 12 up to Week 176 (16 weeks after last dose)

  24. Part 2, extension: Occurrence of anti-Mim8 antibodies

    Count

    Measured: From Week 12 up to Week 176 (16 weeks after last dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start10 Jan 2020
  3. Primary completion6 Oct 2023
  4. Study completion6 Oct 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1 placebo-controlled double-blind within cohorts (phase 1) Part 2 open-label (phase 2)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04204408
Sponsor's protocol ID
NN7769-4513
Other IDs
U1111-1227-4220, 2019-000465-20, 2019
Acronym
FRONTIER1
Status last verified
Dec 2025
First submitted
17 Dec 2019
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Chowdary P, Lentz SR, Gil L, Lopez-Jaime FJ, Windyga J, Ong Clausen WH, Laursen PN, Mahlangu J. FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in people with hemophilia A. Res Pract Thromb Haemost. 2025 Oct 8;9(7):103207. doi: 10.1016/j.rpth.2025.103207. eCollection 2025 Oct.

    PubMed 41246456

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0365-3769 (Mim8) in people with Healthy Volunteers and Haemophilia A With or Without Inhibitors, run by Novo Nordisk A/S at 40 sites in 12 countries.

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 9 inclusion and 19 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: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Japan, Poland, Spain, Turkey (Türkiye) and 7 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of treatment emergent adverse events (time frame: From time of dosing (Day 1) to Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204408, which also lists 1 linked publication.

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 19 Dec 2025.

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