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

NCT07525791 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9662-8158U1111-1328-3457
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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)

  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)

  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

  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

  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

  Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step

Study Arms (1)

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.

Drug: NNC0662-0419; Drug: Oral contraceptive; Drug: Acetaminophen

Interventions

NNC0662-0419 DRUG

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

NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen

Oral contraceptive DRUG

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

NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen

Acetaminophen DRUG

A single dose of acetaminophen will be administered orally.

NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Female (sex assigned at birth) of non-childbearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Contraceptives, Oral; Acetaminophen

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): May 4, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)