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

April 21, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Recruiting
        • Altasciences Clinical Kansas, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen
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.
Drug: NNC0662-0419
Once-weekly subcutaneous NNC0662-0419 will be administered using a pen injector
Drug: Oral contraceptive
An oral contraceptive Altavera [levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg] will be administered orally.
Drug: Acetaminophen
A single dose of acetaminophen will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: Day 8 and 1 day after last NNC0662-0419 dose
Measured as h*pg/mL
Day 8 and 1 day after last NNC0662-0419 dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Measured as pg/mL
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
Measured as pg/mL
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
Measured as microgram per milliliter (h*μg/mL)
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
Measured as h*μg/mL
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
Measured as μg/mL
Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 8, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9662-8158
  • U1111-1328-3457 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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