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CompletedPhase 1

A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

A Non-randomised, Open-label Phase I Trial to Evaluate the Effect of BI 456906 at Different Dose Levels of Multiple Subcutaneous Doses in a Titration Scheme on the Single Dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Otherwise Healthy Women With Overweight/Obesity

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

32

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 27-40FemaleHealthy volunteers

Primary endpoints

AUC of ethinylestradiol in plasma over the time interval from 0 to the lastMaximum measured concentration of ethinylestradiol in plasma (Cmax)AUC of levonorgestrel in plasma over the time interval from 0 to the last

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 IDNCT05896384
Org study ID1404-0014
Secondary ID2022-503146-53-00CTIS

Timeline

Milestones

Study first posted2023-06-09actual
Study start2023-12-21actual
Primary completion2025-02-14actual
Study completion2025-03-26actual
Last update posted2025-04-16actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

1. Otherwise healthy women according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

2. Age of 18 to 60 years (inclusive)

3. Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive)

4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial, i.e. prior to starting any screening procedures

5. Subject fulfills any of the following criteria at least 4 weeks prior to allocation of subject number (i.e. prior to Day 1 of period 1):

1. Use of non-hormone releasing intrauterine device (IUD) and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom

2. Bilateral tubal ligation and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom

3. Sexually abstinent (i.e. subjects must abstain from male-female sex)

4. Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy)

5. Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and/or liver enzymes (alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT)) and/or pancreatic enzymes (amylase lipase) above upper limit of normal range +10% at screening examination, confirmed by a repeat test

4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. History of either chronic or acute pancreatitis

7. Cholecystectomy, and/or prior surgery of the gastrointestinal (GI) tract (including bariatric surgery) or any relevant anatomical malformation of the GI tract that could interfere with the pharmacokinetics of the trial medication (investigational medicinal product (IMP) or auxiliary medicinal product (AxMP)) - except appendectomy or simple hernia repair

8. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

9. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Endpoints (4)

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

4 endpoints
Primary/protocol endpoint

Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

Time frame:up to Week 29

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum measured concentration of ethinylestradiol in plasma (Cmax)

Time frame:up to Week 29

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

Time frame:up to Week 29

concentration, descriptive

Primary/protocol endpoint

Maximum measured concentration of levonorgestrel in plasma (Cmax)

Time frame:up to Week 29

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.