Diabetes Mellitus, Type 2Phase 1NCT06513104
A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause
A Phase 1 study testing NNC0519-0130, Levonorgestrel + Ethinylestradiol and Paracetamol in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The purpose of the study is to investigate if NNC0519-0130 affects the blood levels of a birth control pill that contains the two hormones ethinylestradiol and levonorgestrel. The study will also look into if NNC0519-0130 affects how fast stomach is emptied. Read more about this study
- Who is it for?
- Ages Up to 45 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- NNC0519-0130, Levonorgestrel + Ethinylestradiol and Paracetamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2024to 30 Sep 2025
- 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 Up to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Postmenopausal female.
- Age greater than or equal to (≥)45 years at the time of signing informed consent.
- Body weight ≥ 60 kilogram (kg).
- Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be otherwise 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, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimoles per mole (mmol/mol)) at screening.
- Any contraindications for the use of the oral contraception used in the study according to the Microgynon Summary of Product Characteristics, including:
- Presence or risk of venous thromboembolism or arterial thromboembolism, e.g., history of migraine with focal neurological symptoms or transitory ischemic attacks.
- Undiagnosed vaginal bleeding.
- Presence or history of breast cancer.
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- Presence or history of liver tumours (benign or malignant).
- Positive family history of arterial thromboembolism and/or venous thromboembolism (ever in a sibling or parent especially at relatively early age e.g. below 50).
- Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and anti-phospholipid antibodies (anticardiolipinantibodies, lupus anticoagulant).
- Known hereditary or acquired predisposition to venous thromboembolism, such as Activated Protein C (APC) resistance (including factor V Leiden), antithrombin III deficiency, protein C deficiency or protein S deficiency.
- Dyslipoproteinaemia.
- Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- Use of hormone replacement therapy within 4 weeks before screening or intention to initiate treatment with hormone replacement therapy during the study.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of NNC0519-0130 on the Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Healthy Postmenopausal Females
The purpose of the study is to investigate if NNC0519-0130 affects the blood levels of a birth control pill that contains the two hormones ethinylestradiol and levonorgestrel. The study will also look into if NNC0519-0130 affects how fast stomach is emptied. Participants will get the new study medicine NNC0519-0130 and will also get birth control pills and paracetamol. The study will last for about 35 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0519-0130, Levonorgestrel + Ethinylestradiol, Paracetamol
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0519-0130Drug
NNC0519-0130 will be administered subcutaneously.
Levonorgestrel + EthinylestradiolDrug
Levonorgestrel + Ethinylestradiol will be administered orally.
ParacetamolDrug
Paracetamol will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| NNC0519-0130 + OC+ paracetamol | Experimental | All participants will initiate treatment with paracetamol (once) and oral contraceptive (Levonorgestrel + Ethinylestradiol) treatment only followed by a period with NNC0519-0130 treatment only, thereafter a period with NNC0519-0130, paracetamol (once) and oral contraceptive treatment. Receives: Drug: NNC0519-0130; Drug: Levonorgestrel + Ethinylestradiol; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state
Measured in hours picograms per milliliter (h*pg/mL).
Measured: Day 8
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state
Measured in h*pg/mL.
Measured: Day 188
Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state
Measured in h*pg/mL.
Measured: Day 8
Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state
Measured in h*pg/mL.
Measured: Day 188
Secondary outcomes (5)
Maximum ethinylestradiol plasma concentration at steady state
Measured in picograms per milliliter (pg/mL).
Measured: Day 8 and Day 188
Maximum levonorgestrel plasma concentration at steady state
Measured in pg/mL.
Measured: Day 8 and Day 188
Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal
Measured in hours micrograms per milliliter (h*μg/mL).
Measured: Day 1 and Day 181
Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal
Measured in h*μg/mL.
Measured: Day 1 and Day 181
Maximum paracetamol plasma concentration following a standardised meal
Measured in micrograms per milliliter (μg/mL).
Measured: Day 1 and Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start18 Jul 2024
- Primary completion10 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513104
- Sponsor's protocol ID
- NN9541-4922
- Other IDs
- U1111-1294-3433, 2023-507973-16, 2023
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2024
- Last updated
- 12 Mar 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of NNC0519-0130 on the Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Healthy Postmenopausal Females
- ClinicalTrials.gov ID
- NCT06513104
- Acronym / sponsor ID
- NN9541-4922
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 22 Jul 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.
The purpose of the study is to investigate if NNC0519-0130 affects the blood levels of a birth control pill that contains the two hormones ethinylestradiol and levonorgestrel. The study will also look into if NNC0519-0130 affects how fast stomach is emptied. Participants will get the new study medicine NNC0519-0130 and will also get birth control pills and paracetamol. The study will last for about 35 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NNC0519-0130 + OC+ paracetamol | Experimental | Drug: NNC0519-0130, Drug: Levonorgestrel + Ethinylestradiol, Drug: ParacetamolAll participants will initiate treatment with paracetamol (once) and oral contraceptive (Levonorgestrel + Ethinylestradiol) treatment only followed by a period with NNC0519-0130 treatment only, thereafter a period with NNC0519-0130, paracetamol (once) and oral contraceptive treatment. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Postmenopausal female.
- Age greater than or equal to (≥)45 years at the time of signing informed consent.
- Body weight ≥ 60 kilogram (kg).
- Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be otherwise 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 (14 listed)
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimoles per mole (mmol/mol)) at screening.
- Any contraindications for the use of the oral contraception used in the study according to the Microgynon Summary of Product Characteristics, including:
- Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- Use of hormone replacement therapy within 4 weeks before screening or intention to initiate treatment with hormone replacement therapy during the study.
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 |
|---|---|---|
| NNC0519-0130NNC0519-0130 will be administered subcutaneously. | Drug | NNC0519-0130 + OC+ paracetamol |
| Levonorgestrel + EthinylestradiolLevonorgestrel + Ethinylestradiol will be administered orally. | Drug | NNC0519-0130 + OC+ paracetamol |
| ParacetamolParacetamol will be administered orally. | Drug | NNC0519-0130 + OC+ paracetamol |
Primary outcome
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state
Time frame: Day 8
Measured in hours picograms per milliliter (h*pg/mL).
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state
Time frame: Day 188
Measured in h*pg/mL.
Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state
Time frame: Day 8
Measured in h*pg/mL.
Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state
Time frame: Day 188
Measured in h*pg/mL.
5 secondary outcomes
Maximum ethinylestradiol plasma concentration at steady state
Time frame: Day 8 and Day 188
Maximum levonorgestrel plasma concentration at steady state
Time frame: Day 8 and Day 188
Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal
Time frame: Day 1 and Day 181
Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal
Time frame: Day 1 and Day 181
Maximum paracetamol plasma concentration following a standardised meal
Time frame: Day 1 and Day 181
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 12 Mar 2026.
- 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 NNC0519-0130, Levonorgestrel + Ethinylestradiol and Paracetamol in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
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 5 inclusion and 14 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 12 Mar 2026. 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 Germany. 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?
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state (time frame: Day 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.