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Replacement Therapy

NNC0365-3769 (Mim8) for Haemophilia A (FRONTIER1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 12 up to week 176 (16 weeks after last dose)
Awards & highlights

FRONTIER1 Trial Summary

This trial is investigating a new medication, Mim8, for the prevention of bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII).

Eligible Conditions
  • Haemophilia A
  • Healthy Subjects

FRONTIER1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 12 up to week 176 (16 weeks after last dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 12 up to week 176 (16 weeks after last dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of treatment emergent adverse events
Part 2, extension: Number of treatment emergent adverse events
Part 2: Number of treatment emergent adverse events
Secondary outcome measures
Part 1: AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose
Part 1: Change in activated partial thromboplastin time
Part 1: Cmax, SD: the maximum concentration of Mim8 after a single dose
+21 more

FRONTIER1 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Single dose (part 1) Mim8Experimental Treatment1 Intervention
Blinded. Single doses in healthy volunteers. Dose escalation. In each of the 6 cohorts, 6 participants will receive Mim8.
Group II: Multiple dose (part 2)Experimental Treatment1 Intervention
Open-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.
Group III: Single dose (part 1) placeboPlacebo Group1 Intervention
Blinded. Single doses in healthy volunteers. In each of the 6 cohorts, 2 participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0365-3769 (Mim8)
2020
Completed Phase 2
~480

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,754 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
102,979 Total Patients Enrolled

Media Library

Mim8 (Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04204408 — Phase 2
Haemophilia A Research Study Groups: Single dose (part 1) Mim8, Multiple dose (part 2), Single dose (part 1) placebo
Haemophilia A Clinical Trial 2023: Mim8 Highlights & Side Effects. Trial Name: NCT04204408 — Phase 2
Mim8 (Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04204408 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being sought out for this particular clinical trial?

"This study includes 12 to 64-year-olds, as per the requirements for participants."

Answered by AI

Has the FDA cleared NNC0365-3769 (Mim8) for use?

"NNC0365-3769 (Mim8) is still in Phase 2 of clinical trials, so there is only preliminary data supporting its safety. However, there are no current data suggesting it is an effective medication."

Answered by AI

Are there different research locations within Canada conducting this trial?

"This study is being conducted at 8 different sites, with the nearest ones to major cities being in Iowa City, Ann Arbor and Charlotte. It is worth considering enrolling at the closest location to you to limit travel."

Answered by AI

What outcomes does this research seek?

"The primary outcome of this 16-week study will be Part 2: Number of treatment emergent adverse events. Additionally, the trial will measure Part 2 (weekly and monthly dosing): Relative change in prothrombin fragment 1 and 2, Part 1: Relative change in prothrombin fragment 1 and 2, and Part 1: tmax, SD: the time to maximum concentration of Mim8 after a single dose."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
A Research Study Investigating Mim8 in People With Haemophilia A
2020. "A Research Study Investigating Mim8 in People With Haemophilia A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04204408.
~52 spots leftby Apr 2025
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