Recruiting
Phase 1

NNC0662-0419, Altavera, Acetaminophen

Sponsor:

Novo Nordisk A/S

Code:

NCT07525791

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

NNC0662-0419

Oral contraceptive

Acetaminophen

Study Details

Brief 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. 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

Study ID

NCT07525791

Start date

Apr 7, 2026

Status verified date

Apr, 2026

Completion date

May 4, 2027

Anticipated

Primary completion date

Apr 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

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 Design

Enrollment

45 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

NNC0662-0419

Once-weekly subcutaneous NNC0662-0419 will be administered using a pen injector

Oral contraceptive

An oral contraceptive Altavera \[levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg\] will be administered orally.

Acetaminophen

A single dose of acetaminophen will be administered orally.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Altasciences Clinical Kansas, Inc.

Recruiting

Overland Park, Kansas, United States, 66212

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-04-24.