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CompletedPhase 1

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

1

Recruiting sites

Enrollment

43

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 25-39.9Female

Primary endpoints

AUC of ethinylestradiol at steady stateAUC of levonorgestrel at steady state

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06461039
Org study IDNN9487-7612
Secondary IDU1111-1300-3685World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-06-14actual
Study start2024-06-14actual
Primary completion2025-03-16actual
Study completion2025-04-04actual
Last update posted2025-05-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

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.

Exclusion criteria

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

14 endpoints
Primary/protocol endpoint

The area under the ethinylestradiol plasma concentration time curve at steady state

Time frame:Day 8 and Day 193

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

The area under the levonorgestrel plasma concentration time curve at steady state

Time frame:Day 8 and Day 193

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum ethinylestradiol plasma concentration at steady state

Time frame:Day 8 and Day 193

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum levonorgestrel plasma concentration at steady state

Time frame:Day 8 and Day 193

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

The area under the ethinylestradiol plasma concentration time curve at steady state

Time frame:Day 8 and Day 135

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

The area under the levonorgestrel plasma concentration time curve at steady state

Time frame:Day 8 and Day 135

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state

Time frame:Day 8 and Day 135

Cmax

concentration, descriptive

Secondary/protocol endpoint

Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state

Time frame:Day 8 and Day 135

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC1 area under the acetaminophen concentration-time curve following a standardised meal

Time frame:Day 1 and Day 186

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC2 area under the acetaminophen concentration-time curve following a standardised meal

Time frame:Day 1 and Day 186

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,para, maximum acetaminophen plasma concentration following a standardised meal

Time frame:Day 1 and Day 186

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC3 area under the acetaminophen concentration-time curve following a standardised meal

Time frame:Day 1 and Day 128

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC4 area under the acetaminophen concentration-time curve following a standardised meal

Time frame:Day 1 and Day 128

concentration, descriptive

Secondary/protocol endpoint

Cmax,para, maximum acetaminophen plasma concentration following a standardised meal

Time frame:Day 1 and Day 128

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.