Healthy Volunteers (Non-alcoholic Steatohepatitis)Phase 1NCT06188026

A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children.

A Phase 1 study testing NNC0194-0499 and ethinylestradiol/levonorgestrel in people with Healthy Volunteers (Non-alcoholic Steatohepatitis), run by Novo Nordisk A/S at 1 site in Austria.

Completed

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

Official record

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Trial summary

The study will investigate the influence of NNC0194-0499 on the blood levels of the two components of a birth control pill, Microgynon®. Participants will get the birth control pill in form of tablets in two periods of 8 days each. Participants will get NNC0194-0499 as injection under the skin of their thigh. Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers (Non-alcoholic Steatohepatitis)
What is being tested?: NNC0194-0499 and ethinylestradiol/levonorgestrel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteAustria
Study dates: 18 Dec 2023to 30 Dec 2024
Phase: Phase 1
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 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female of non-childbearing potential.
Age 18-65 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) at screening.
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.

Who cannot join

Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Any contraindications for the use of the oral contraception used in the study according to the Prescription Drug Information.
Sitting blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic.
Pulse outside the range of 50-89 beats/minute at screening
Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reaching systemic circulation.
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Graz
Graz, 8010

Other trials in Austria

About this study

Official title: Investigation of the Effect of NNC0194-0499 on Pharmacokinetics of a Combined Oral Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential. .

Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks.

The study will last for about 11 to 15 weeks, depending on the length of the screening period.

Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.

Conditions: Healthy Volunteers (Non-alcoholic Steatohepatitis)
Being tested: NNC0194-0499, ethinylestradiol/levonorgestrel
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

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

NNC0194-0499Drug
Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin
ethinylestradiol/levonorgestrelDrug
Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel.

Study groups in NCT06188026
Study group	Role	What they receive
Sequence 1	Experimental	All participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week. Receives: Drug: NNC0194-0499; Drug: ethinylestradiol/levonorgestrel

What is being measured

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

(AUC0-24h,EE,SS), area under the ethinylestradiol plasma concentration-time curve during a dosing interval at steady state
h-pg/mL
Measured: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(AUC0-24h,LN,SS), area under the levonorgestrel plasma concentration-time curve during a dosing interval at steady state
h-pg/mL
Measured: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)

Secondary outcomes (5)

(Cmax,EE,SS), maximum concentration of ethinylestradiol at steady state
pg/mL
Measured: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(Cmax,LN,SS), maximum concentration of levonorgestrel at steady state
pg/mL
Measured: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(tmax,EE,SS), time to maximum concentration of ethinylestradiol at steady state
hours
Measured: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(tmax,LN,SS), time to maximum concentration of levonorgestrel at steady state
hours
Measured: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
Number of treatment emergent adverse events (TEAEs)
Number of events
Measured: Day 1 to Day 8, and Day 31 to Day 38.

Timeline

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

18 Dec 202330 Dec 2024

First posted3 Jan 2024
Study start18 Dec 2023
Primary completion30 Dec 2024
Study completion30 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Volunteers (Non-alcoholic Steatohepatitis)Studies 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: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: single-centre, one-sequence cross-over, open-label study
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06188026
Sponsor's protocol ID: NN9500-4619
Other IDs: U1111-1279-3843, 2023-503595-24-00, 2023
Status last verified: Feb 2025
First submitted: 14 Dec 2023
Last updated: 18 Feb 2025
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"

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers (Non-alcoholic Steatohepatitis) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effect of NNC0194-0499 on Pharmacokinetics of a Combined Oral Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential. .
ClinicalTrials.gov ID: NCT06188026
Acronym / sponsor ID: NN9500-4619
Conditions: Healthy Volunteers (Non-alcoholic Steatohepatitis)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 18 Dec 2023 (actual)
Primary completion: 30 Dec 2024 (actual)
Study completion: 30 Dec 2024 (actual)
First posted: 3 Jan 2024 (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.

Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks.

The study will last for about 11 to 15 weeks, depending on the length of the screening period.

Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: single-centre, one-sequence cross-over, open-label study

Arm	Type	Receives
Sequence 1	Experimental	Drug: NNC0194-0499, Drug: ethinylestradiol/levonorgestrelAll participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female of non-childbearing potential.
Age 18-65 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) at screening.
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.

Key exclusion criteria (6 listed)

Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Any contraindications for the use of the oral contraception used in the study according to the Prescription Drug Information.
Sitting blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic.
Pulse outside the range of 50-89 beats/minute at screening
Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reaching systemic circulation.

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
NNC0194-0499Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin	Drug	Sequence 1
ethinylestradiol/levonorgestrelOral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel.	Drug	Sequence 1

Primary outcome

(AUC0-24h,EE,SS), area under the ethinylestradiol plasma concentration-time curve during a dosing interval at steady state
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
h-pg/mL
(AUC0-24h,LN,SS), area under the levonorgestrel plasma concentration-time curve during a dosing interval at steady state
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
h-pg/mL

5 secondary outcomes

(Cmax,EE,SS), maximum concentration of ethinylestradiol at steady state
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(Cmax,LN,SS), maximum concentration of levonorgestrel at steady state
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(tmax,EE,SS), time to maximum concentration of ethinylestradiol at steady state
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(tmax,LN,SS), time to maximum concentration of levonorgestrel at steady state
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
Number of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 8, and Day 31 to Day 38.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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. This study is not recruiting at the moment.

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 NNC0194-0499 and ethinylestradiol/levonorgestrel in people with Healthy Volunteers (Non-alcoholic Steatohepatitis), run by Novo Nordisk A/S at 1 site in Austria.

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 6 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 18 Feb 2025. 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 Austria. 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?

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?

(AUC0-24h,EE,SS), area under the ethinylestradiol plasma concentration-time curve during a dosing interval at steady state (time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)). The study lists 2 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 NCT06188026.

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 18 Feb 2025.