DelfaGLP-1 Atlas

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CompletedPhase 1

Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant

Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

1

Recruiting sites

—

Enrollment

31

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 25-39.9•Female

Primary endpoints

•AUC0-24h,EE,SS AUC of ethinylestradiol during a dosing interval (0-24 hours)•AUC0-24h,LN,SS AUC of levonorgestrel during a dosing interval (0-24 hours)

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 IDNCT04074174
Org study IDNN9838-4517
Secondary IDU1111-1228-4219World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-08-29actual
Study start2019-09-12actual
Primary completion2020-03-06actual
Study completion2020-03-06actual
Last update posted2022-01-10actual

Assets

Investigational agents

CagriSema / cagrilintide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•Female of non-childbearing potential, aged 18-65 years (both inclusive) at the time of signing informed consent.
•Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion criteria

•Known or suspected hypersensitivity to trial products (including acetaminophen) or related products.
•Previous participation in this trial. Participation is defined as signed informed consent.
•Previous participation in trial(s) with NNC0174-0833 unless documented that the subject was assigned to placebo treatment. Participation is defined as randomised.
•Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Endpoints (8)

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

8 endpoints
Primary/protocol endpoint

AUC0-24h,EE,SS area under the ethinylestradiol concentration-time curve during a dosing interval (0-24 hours) at steady state

Time frame:Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state

Time frame:Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,EE,SS time to maximum concentration of ethinylestradiol at steady state

Time frame:Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

Tmax

concentration, descriptive

Secondary/protocol endpoint

tmax,LN,SS, time to maximum concentration of levonorgestrel at steady state

Time frame:Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

Tmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-60min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-60 minutes following a standardised meal

Time frame:Day 1 (predose to 60 minutes post-dose) and Day 79 (predose to 60 minutes post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-360min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-360 minutes following a standardised meal

Time frame:Day 1 (predose to 360 minutes post-dose) and Day 79 (predose to 360 minutes post-dose)

AUC₀–∞

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.