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Diabetes Mellitus, Type 2Phase 1NCT05153564

A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause

A Phase 1 study testing Semaglutide 1.34 mg/mL, Semaglutide 3.0 mg/mL and NNC0480-0389 10 mg/mL in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.

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

Novo Nordisk is developing a combination therapy with the investigational drug NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. Read more about this study

Who is it for?
Ages 45 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide 1.34 mg/mL, Semaglutide 3.0 mg/mL and NNC0480-0389 10 mg/mL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteGermany
Study dates
13 Dec 2021to 1 Sep 2022
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 45 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent
  • Body mass index between 20.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive)
  • 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
  • HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening
  • Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 enzyme (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 first dose of trial product 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.

Germany1 site

  • Novo Nordisk Investigational Site

    Berlin, 10117

Other trials in Germany

About this study

Official title: Investigation of the Effect of Subcutaneously Co-administered Semaglutide and NNC0480-0389 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Healthy Postmenopausal Females

Novo Nordisk is developing a combination therapy with the investigational drug NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. The study will investigate the influence of the combination of semaglutide and NNC0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol. Participants will get semaglutide and NNC0480-0389 as injection under the skin of their belly using a pen-injector. The injections will be given once weekly for 14 weeks. Additionally, participants will at two occasions get paracetamol as soluble tablet in connection with a standardised breakfast meal. Further, participants will get the birth control pill in form of tablets in two periods of 8 days each. Participants will get the combination of semaglutide and NNC0480-0389 as well as paracetamol and the combined contraceptive in any case. The study participation will last up to about 24 weeks. Participants will have 25 visits at the study centre. For 4 of the visits participants will stay at the study centre; the remaining visits will be outpatient. Only healthy postmenopausal women can take part in this study.

Being tested
Semaglutide 1.34 mg/mL, Semaglutide 3.0 mg/mL, NNC0480-0389 10 mg/mL, NNC0480-0389 30 mg/mL, Microgynon®
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.

  • Semaglutide 1.34 mg/mLDrug

    Semaglutide will be administered at a dose of 0.25, 0.50 or 1.0 mg as indicated on scale drum once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks.

  • Semaglutide 3.0 mg/mLDrug

    Semaglutide will be administered at a dose of 2.0 mg corresponding to the increment of 67 (pen injector units) as indicated on scale drum. once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks.

  • NNC0480-0389 10 mg/mLDrug

    NNC0480-0389 will be administered at a dose of 0.23, 0.45 or 0.90 mL once weekly by s.c. (under the skin) injections for 14 weeks.

  • NNC0480-0389 30 mg/mLDrug

    NNC0480-0389 will be administered at a dose of 0.60 mL once weekly by s.c. (under the skin) injections for 14 weeks.

  • Microgynon®Drug

    Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.

Study groups in NCT05153564
Study groupRoleWhat they receive
One-sequence cross-over armExperimentalNot described
Receives: Drug: Semaglutide 1.34 mg/mL; Drug: Semaglutide 3.0 mg/mL; Drug: NNC0480-0389 10 mg/mL; Drug: NNC0480-0389 30 mg/mL; Drug: Microgynon®

What is being measured

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

  1. Area under the ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS)

    Measured in h*pg/mL

    Measured: From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

  2. Area under the levonorgestrel plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,LN,SS)

    Measured in h*pg/mL

    Measured: From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

Secondary outcomes (5)

  1. Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS)

    Measured in pg/mL

    Measured: Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

  2. Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS)

    Measured in pg/mL

    Measured: Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

  3. Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para)

    Measured in h*μg/mL

    Measured: From pre-dose to 60 minutes after dosing of paracetamol on day 1 and day 93

  4. Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para)

    Measured in h*μg/mL

    Measured: From pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93

  5. Maximum observed paracetamol concentration following a standardised meal (Cmax,para)

    Measured in μg/mL

    Measured: Within pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93

Timeline

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

  1. First posted10 Dec 2021
  2. Study start13 Dec 2021
  3. Primary completion13 Aug 2022
  4. Study completion1 Sep 2022

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153564
Sponsor's protocol ID
NN9389-4681
Other IDs
2021-003060-27, U1111-1266-3910
Status last verified
Nov 2023
First submitted
8 Dec 2021
Last updated
13 Nov 2023
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Semaglutide 1.34 mg/mL, Semaglutide 3.0 mg/mL and NNC0480-0389 10 mg/mL 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 3 inclusion and 5 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 13 Nov 2023. 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 (0 to 24 hours) at steady state (AUC0-24h,EE,SS) (time frame: From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100). 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 NCT05153564.

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 13 Nov 2023.

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