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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
Lead sponsor
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 27-40•Female•Healthy volunteers
Primary endpoints
•AUC of ethinylestradiol in plasma over the time interval from 0 to the last•Maximum 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsArea 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
Maximum measured concentration of ethinylestradiol in plasma (Cmax)
Time frame:up to Week 29
Cmax
concentration, descriptive
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
Maximum measured concentration of levonorgestrel in plasma (Cmax)
Time frame:up to Week 29
Cmax
concentration, descriptive
Provenance
Sources
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.