OverweightPhase 1NCT04074174
Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant
A Phase 1 study testing NNC0174-0833, Oral contraceptive (OC) tablets and Acetaminophen in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
The study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0174-0833, Oral contraceptive (OC) tablets and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2019to 6 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female of non-childbearing potential, aged 18-65 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to trial products (including acetaminophen) or related products.
- Previous participation in this trial. Participation is defined as signed informed consent.
- Previous participation in trial(s) with NNC0174-0833 unless documented that the subject was assigned to placebo treatment. Participation is defined as randomised.
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential
The study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold in the stomach. In addition, participants will get 1 birth control pill per day for 8 days before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Participants will also get a dose of acetaminophen before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a mild painkiller but used here to assess the emptying of the stomach. The study will last for about 9 months, but participants will only be in the study for about 6 months. Participants will have 17 clinic visits with the study staff and some will be overnight visits. There will also be 3 phone calls with the study staff. At all visits, participants will have blood drawn along with other clinical assessments. Participants will be asked about their health, diseases and habits including mental health questionnaires. Participants must not be able to become pregnant if they want to participate in the study.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0174-0833, Oral contraceptive (OC) tablets, Acetaminophen
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0174-0833Drug
NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks
Oral contraceptive (OC) tabletsDrug
1 tablet daily on days 1-8 and days 79-86
AcetaminophenDrug
Single dose of acetaminophen as part of a standardised meal on day 1 and day 79
| Study group | Role | What they receive |
|---|---|---|
| NNC0174-0833 treatment-free period; NNC0174-0833 treatment | Experimental | During the NNC0174-0833 treatment-free period participants will receive OC tablets and acetaminophen. During the NNC0174-0833 treatment period participants will receive OC tablets and acetaminophen in addition to NNC0174-0833. Receives: Drug: NNC0174-0833; Drug: Oral contraceptive (OC) tablets; Drug: Acetaminophen |
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 concentration-time curve during a dosing interval (0-24 hours) at steady state
h*pg/mL
Measured: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state
h*pg/mL
Measured: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Secondary outcomes (6)
Cmax,EE, SS, maximum concentration of ethinylestradiol at steady state
pg/mL
Measured: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Cmax,LN,SS, maximum concentration of levonorgestrel at steady state
pg/mL
Measured: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
tmax,EE,SS time to maximum concentration of ethinylestradiol at steady state
h
Measured: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
tmax,LN,SS, time to maximum concentration of levonorgestrel at steady state
h
Measured: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
AUC0-60min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-60 minutes following a standardised meal
h*microg/mL
Measured: Day 1 (predose to 60 minutes post-dose) and Day 79 (predose to 60 minutes post-dose)
AUC0-360min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-360 minutes following a standardised meal
h*microg/mL
Measured: Day 1 (predose to 360 minutes post-dose) and Day 79 (predose to 360 minutes post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start12 Sep 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074174
- Sponsor's protocol ID
- NN9838-4517
- Other IDs
- U1111-1228-4219
- Status last verified
- Jan 2022
- First submitted
- 28 Aug 2019
- Last updated
- 10 Jan 2022
- 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 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential
- ClinicalTrials.gov ID
- NCT04074174
- Acronym / sponsor ID
- NN9838-4517
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 29 Aug 2019 (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 study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold in the stomach. In addition, participants will get 1 birth control pill per day for 8 days before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Participants will also get a dose of acetaminophen before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a mild painkiller but used here to assess the emptying of the stomach. The study will last for about 9 months, but participants will only be in the study for about 6 months. Participants will have 17 clinic visits with the study staff and some will be overnight visits. There will also be 3 phone calls with the study staff. At all visits, participants will have blood drawn along with other clinical assessments. Participants will be asked about their health, diseases and habits including mental health questionnaires. Participants must not be able to become pregnant if they want to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NNC0174-0833 treatment-free period; NNC0174-0833 treatment | Experimental | Drug: NNC0174-0833, Drug: Oral contraceptive (OC) tablets, Drug: AcetaminophenDuring the NNC0174-0833 treatment-free period participants will receive OC tablets and acetaminophen. During the NNC0174-0833 treatment period participants will receive OC tablets and acetaminophen in addition to NNC0174-0833. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female of non-childbearing potential, aged 18-65 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to trial products (including acetaminophen) or related products.
- Previous participation in this trial. Participation is defined as signed informed consent.
- Previous participation in trial(s) with NNC0174-0833 unless documented that the subject was assigned to placebo treatment. Participation is defined as randomised.
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
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 |
|---|---|---|
| NNC0174-0833NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks | Drug | NNC0174-0833 treatment-free period; NNC0174-0833 treatment |
| Oral contraceptive (OC) tablets1 tablet daily on days 1-8 and days 79-86 | Drug | NNC0174-0833 treatment-free period; NNC0174-0833 treatment |
| AcetaminophenSingle dose of acetaminophen as part of a standardised meal on day 1 and day 79 | Drug | NNC0174-0833 treatment-free period; NNC0174-0833 treatment |
Primary outcome
AUC0-24h,EE,SS area under the ethinylestradiol concentration-time curve during a dosing interval (0-24 hours) at steady state
Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
h*pg/mL
AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state
Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
h*pg/mL
6 secondary outcomes
Cmax,EE, SS, maximum concentration of ethinylestradiol at steady state
Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Cmax,LN,SS, maximum concentration of levonorgestrel at steady state
Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
tmax,EE,SS time to maximum concentration of ethinylestradiol at steady state
Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
tmax,LN,SS, time to maximum concentration of levonorgestrel at steady state
Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
AUC0-60min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-60 minutes following a standardised meal
Time frame: Day 1 (predose to 60 minutes post-dose) and Day 79 (predose to 60 minutes post-dose)
AUC0-360min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-360 minutes following a standardised meal
Time frame: Day 1 (predose to 360 minutes post-dose) and Day 79 (predose to 360 minutes post-dose)
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 10 Jan 2022.
- 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 Reporting Anchor and Disclosure (1452) 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 NNC0174-0833, Oral contraceptive (OC) tablets and Acetaminophen in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Canada.
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 2 inclusion and 4 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 10 Jan 2022. 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 Canada. 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 concentration-time curve during a dosing interval (0-24 hours) at steady state (time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose 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?
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 10 Jan 2022.