Healthy, Obesity, Overweight
Conditions
Brief summary
The primary objective of this trial is to assess bioequivalence of two formulations of survodutide (formulation A and formulation B6) after multiple-dose treatment in male and female trial participants living with overweight or obesity.
Interventions
COMBINATION_PRODUCTFormulation A
Formulation A of survodutide
COMBINATION_PRODUCTFormulation B6
Formulation B6 of survodutide
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female trial participant 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 65 years (inclusive) 3. Body Mass Index (BMI) of 27.0 to 39.9 Kg/ m\^2 (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 5. For women of child-bearing potential (WOCBP) trial participants: Woman of childbearing potential (WOCBP) trial participants who meet any of the following criteria for a highly effective contraception from at least 28 days before the first administration of trial medication until 28 days after trial completion: * Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal). In case of oral contraception, a barrier method should be used in addition or advised to change to non-oral contraceptives at least 7 days prior to first dose of investigational medicine product (IMP) * Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants). In case of oral contraception, a barrier method should be used in addition or advised to change to non-oral contraceptives at least 7 days prior to first dose of IMP * Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) * Complete abstinence (refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) is considered a highly effective method of contraception only if it is in line with the preferred and usual lifestyle of the trial participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to trial IMP, spermicides only, lactational amenorrhoea method (LAM) and withdrawal are not acceptable methods of contraception * Bilateral tubal ligation/occlusion is considered a highly effective method of contraception, provided that the procedure has not been reversed or failed. * Surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy) * Postmenopausal, defined as no menses for 1 year without an alternative medical cause
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 (BP) outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 100 mmHg, or PR outside the range of 50 to 100 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. 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. Diseases of the Central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 7. History of relevant orthostatic hypotension, fainting spells, or blackouts 8. Relevant chronic or acute infections within the 4 weeks prior to screening Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of survodutide in plasma at steady state over a uniform dosing interval tau (AUC tau,ss) | Up to 239 days. |
| Maximum measured concentration of survodutide in plasma at steady state over a uniform dosing interval tau (Cmax,ss) | Up to 239 days. |
Countries
United Kingdom
Outcome results
None listed