OverweightPhase 1NCT07525791
A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight
A Phase 1 study testing NNC0662-0419, Oral contraceptive and Acetaminophen in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0662-0419, Oral contraceptive 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
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to 18 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female (sex assigned at birth) of non-childbearing potential.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body weight more than or equal to (≥) 60.0 kilogram (kg).
- Considered to be generally healthy, except for overweight or obesity, 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
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Use of any medication containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), or amylin receptor agonism before screening.
- Any contraindications for the use of the oral contraception used in the study according to the Altavera Product Information.
- Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: An Investigation of the Effect of NNC0662-0419 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Women of Non-childbearing Potential With Overweight or Obesity
The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a type of birth control pill, Acetaminophen a common type of mild painkiller.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0662-0419, Oral contraceptive, 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.
NNC0662-0419Drug
Once-weekly subcutaneous NNC0662-0419 will be administered using a pen injector
Oral contraceptiveDrug
An oral contraceptive Altavera [levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg] will be administered orally.
AcetaminophenDrug
A single dose of acetaminophen will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen | Experimental | Participants will receive once-weekly subcutaneous NNC0662-0419, with multiple doses administered over the treatment period. An oral contraceptive will be administered as a number of tablets per treatment period, with dosing conducted under supervised conditions. In addition, a single dose of acetaminophen will be administered as part of a standardized meal during treatment period. Receives: Drug: NNC0662-0419; Drug: Oral contraceptive; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) 0-24 h, EE, steady state (SS): The area under the EE plasma concentration-time curve (pre-dose to 24 hours post-dose)
Measured as picograms per milliliter (h*pg/mL)
Measured: Day 8 and 1 day after last NNC0662-0419 dose
AUC0-24h, LN, SS: The area under the LN plasma concentration-time curve (pre-dose to 24 hours post-dose)
Measured as h*pg/mL
Measured: Day 8 and 1 day after last NNC0662-0419 dose
Secondary outcomes (5)
Maximum concentration (Cmax), EE, SS: Maximum observed EE plasma concentration (pre-dose to 24 hours post-dose)
Measured as pg/mL
Measured: Day 8 and 1 day after last NNC0662-0419 dose
Cmax, LN, SS: Maximum observed LN plasma concentration (pre-dose to 24 hours post-dose)
Measured as pg/mL
Measured: Day 8 and 1 day after last NNC0662-0419 dose
AUC0-60min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 60 minutes post-dose) following a standardised meal
Measured as microgram per milliliter (h*μg/mL)
Measured: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step
AUC0-300min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 300 minutes post-dose) following a standardised meal
Measured as h*μg/mL
Measured: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step
Cmax, para; Maximum observed paracetamol plasma concentration (pre-dose to 300 minutes post-dose) following a standardised meal
Measured as μg/mL
Measured: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start7 Apr 2026
- Primary completion2 May 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT07525791
- Sponsor's protocol ID
- NN9662-8158
- Other IDs
- U1111-1328-3457
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2026
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effect of NNC0662-0419 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Women of Non-childbearing Potential With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07525791
- Acronym / sponsor ID
- NN9662-8158
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 13 Apr 2026 (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 this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a type of birth control pill, Acetaminophen a common type of mild painkiller.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen | Experimental | Drug: NNC0662-0419, Drug: Oral contraceptive, Drug: AcetaminophenParticipants will receive once-weekly subcutaneous NNC0662-0419, with multiple doses administered over the treatment period. An oral contraceptive will be administered as a number of tablets per treatment period, with dosing conducted under supervised conditions. In addition, a single dose of acetaminophen will be administered as part of a standardized meal during treatment period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female (sex assigned at birth) of non-childbearing potential.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body weight more than or equal to (≥) 60.0 kilogram (kg).
- Considered to be generally healthy, except for overweight or obesity, 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 (7 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Use of any medication containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), or amylin receptor agonism before screening.
- Any contraindications for the use of the oral contraception used in the study according to the Altavera Product Information.
- Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, 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 |
|---|---|---|
| NNC0662-0419Once-weekly subcutaneous NNC0662-0419 will be administered using a pen injector | Drug | NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen |
| Oral contraceptiveAn oral contraceptive Altavera [levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg] will be administered orally. | Drug | NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen |
| AcetaminophenA single dose of acetaminophen will be administered orally. | Drug | NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen |
Primary outcome
Area under curve (AUC) 0-24 h, EE, steady state (SS): The area under the EE plasma concentration-time curve (pre-dose to 24 hours post-dose)
Time frame: Day 8 and 1 day after last NNC0662-0419 dose
Measured as picograms per milliliter (h*pg/mL)
AUC0-24h, LN, SS: The area under the LN plasma concentration-time curve (pre-dose to 24 hours post-dose)
Time frame: Day 8 and 1 day after last NNC0662-0419 dose
Measured as h*pg/mL
5 secondary outcomes
Maximum concentration (Cmax), EE, SS: Maximum observed EE plasma concentration (pre-dose to 24 hours post-dose)
Time frame: Day 8 and 1 day after last NNC0662-0419 dose
Cmax, LN, SS: Maximum observed LN plasma concentration (pre-dose to 24 hours post-dose)
Time frame: Day 8 and 1 day after last NNC0662-0419 dose
AUC0-60min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 60 minutes post-dose) following a standardised meal
Time frame: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step
AUC0-300min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 300 minutes post-dose) following a standardised meal
Time frame: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step
Cmax, para; Maximum observed paracetamol plasma concentration (pre-dose to 300 minutes post-dose) following a standardised meal
Time frame: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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 NNC0662-0419, Oral contraceptive and Acetaminophen in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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 curve (AUC) 0-24 h, EE, steady state (SS): The area under the EE plasma concentration-time curve (pre-dose to 24 hours post-dose) (time frame: Day 8 and 1 day after last NNC0662-0419 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 30 Sep 2026.