ObesityPhase 1NCT06461039
A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant
A Phase 1 study testing NNC0487-0111 A, NNC0487-0111 C and Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) in people with Obesity, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- NNC0487-0111 A, NNC0487-0111 C and Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jun 2024to 4 Apr 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females of non-childbearing potential.
- Age 18 - 65 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 25.0 and 39.9 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, unwillingness or inability 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 Microgynon Product Information.
- 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 routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of NNC0487-0111 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Females of Non-childbearing Potential
This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.
- Conditions
- Obesity
- Being tested
- NNC0487-0111 A, NNC0487-0111 C, Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC), Acetaminophen - 500 mg/15 ml
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111 ADrug
NNC0487-0111 A will be administered subcutaneously.
NNC0487-0111 CDrug
NNC0487-0111 C will be taken orally.
Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)Drug
Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.
Acetaminophen - 500 mg/15 mlDrug
Acetaminophen - 500 mg/15 ml will be taken orally.
| Study group | Role | What they receive |
|---|---|---|
| NNC0487-0111 | Experimental | Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4. Receives: Drug: NNC0487-0111 A; Drug: NNC0487-0111 C; Drug: Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC); Drug: Acetaminophen - 500 mg/15 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the ethinylestradiol plasma concentration time curve at steady state
Measured as hours picograms per milliliter (h*pg/mL).
Measured: Day 8 and Day 193
The area under the levonorgestrel plasma concentration time curve at steady state
Measured as hours picograms per milliliter (h*pg/mL).
Measured: Day 8 and Day 193
Secondary outcomes (12)
Maximum ethinylestradiol plasma concentration at steady state
Measured as picograms per milliliter (pg/mL).
Measured: Day 8 and Day 193
Maximum levonorgestrel plasma concentration at steady state
Measured as picograms per milliliter (pg/mL).
Measured: Day 8 and Day 193
The area under the ethinylestradiol plasma concentration time curve at steady state
Measured as hours picograms per milliliter (h*pg/mL).
Measured: Day 8 and Day 135
The area under the levonorgestrel plasma concentration time curve at steady state
Measured as hours picograms per milliliter (h*pg/mL).
Measured: Day 8 and Day 135
Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state
Measured as picograms per milliliter (pg/mL).
Measured: Day 8 and Day 135
Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state
Measured as picograms per milliliter (pg/mL).
Measured: Day 8 and Day 135
AUC1 area under the acetaminophen concentration-time curve following a standardised meal
Measured as hours micro grams per milliliter (h*μg/mL).
Measured: Day 1 and Day 186
AUC2 area under the acetaminophen concentration-time curve following a standardised meal
Measured as hours micro grams per milliliter (h*μg/mL).
Measured: Day 1 and Day 186
Cmax,para, maximum acetaminophen plasma concentration following a standardised meal
Measured as micrograms per milliliter (μg/mL).
Measured: Day 1 and Day 186
AUC3 area under the acetaminophen concentration-time curve following a standardised meal
Measured as hours micro grams per milliliter (h*μg/mL).
Measured: Day 1 and Day 128
AUC4 area under the acetaminophen concentration-time curve following a standardised meal
Measured as hours micro grams per milliliter (h*μg/mL).
Measured: Day 1 and Day 128
Cmax,para, maximum acetaminophen plasma concentration following a standardised meal
Measured as micrograms per milliliter (μg/mL).
Measured: Day 1 and Day 128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start14 Jun 2024
- Primary completion16 Mar 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 43 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
- NCT06461039
- Sponsor's protocol ID
- NN9487-7612
- Other IDs
- U1111-1300-3685
- Status last verified
- May 2025
- First submitted
- 11 Jun 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of NNC0487-0111 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Females of Non-childbearing Potential
- ClinicalTrials.gov ID
- NCT06461039
- Acronym / sponsor ID
- NN9487-7612
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 14 Jun 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.
This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.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 |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111 A, Drug: NNC0487-0111 C, Drug: Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC), Drug: Acetaminophen - 500 mg/15 mlParticipants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females of non-childbearing potential.
- Age 18 - 65 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 25.0 and 39.9 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, unwillingness or inability 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 Microgynon Product Information.
- 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 routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
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 |
|---|---|---|
| NNC0487-0111 ANNC0487-0111 A will be administered subcutaneously. | Drug | NNC0487-0111 |
| NNC0487-0111 CNNC0487-0111 C will be taken orally. | Drug | NNC0487-0111 |
| Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally. | Drug | NNC0487-0111 |
| Acetaminophen - 500 mg/15 mlAcetaminophen - 500 mg/15 ml will be taken orally. | Drug | NNC0487-0111 |
Primary outcome
The area under the ethinylestradiol plasma concentration time curve at steady state
Time frame: Day 8 and Day 193
Measured as hours picograms per milliliter (h*pg/mL).
The area under the levonorgestrel plasma concentration time curve at steady state
Time frame: Day 8 and Day 193
Measured as hours picograms per milliliter (h*pg/mL).
12 secondary outcomes
Maximum ethinylestradiol plasma concentration at steady state
Time frame: Day 8 and Day 193
Maximum levonorgestrel plasma concentration at steady state
Time frame: Day 8 and Day 193
The area under the ethinylestradiol plasma concentration time curve at steady state
Time frame: Day 8 and Day 135
The area under the levonorgestrel plasma concentration time curve at steady state
Time frame: Day 8 and Day 135
Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state
Time frame: Day 8 and Day 135
Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state
Time frame: Day 8 and Day 135
AUC1 area under the acetaminophen concentration-time curve following a standardised meal
Time frame: Day 1 and Day 186
AUC2 area under the acetaminophen concentration-time curve following a standardised meal
Time frame: Day 1 and Day 186
Cmax,para, maximum acetaminophen plasma concentration following a standardised meal
Time frame: Day 1 and Day 186
AUC3 area under the acetaminophen concentration-time curve following a standardised meal
Time frame: Day 1 and Day 128
AUC4 area under the acetaminophen concentration-time curve following a standardised meal
Time frame: Day 1 and Day 128
Cmax,para, maximum acetaminophen plasma concentration following a standardised meal
Time frame: Day 1 and Day 128
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 8 May 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 NNC0487-0111 A, NNC0487-0111 C and Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) in people with 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 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 8 May 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 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?
The area under the ethinylestradiol plasma concentration time curve at steady state (time frame: Day 8 and Day 193). 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 8 May 2025.