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Clinical Trial NCT07407348 for Healthy, Obesity, Overweight is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body Phase 1 80

Recruiting
Clinical Trial NCT07407348 is designed to study Treatment for Healthy, Obesity, Overweight. It is a Phase 1 interventional study that is recruiting, having started on 26 February 2026, with plans to enroll 80 participants. Led by Boehringer Ingelheim, it is expected to complete by 2 March 2027. The latest data from ClinicalTrials.gov was last updated on 17 March 2026.
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.
Official Title

Bioequivalence of Two Survodutide (BI 456906) Formulations Via Subcutaneous Administration After Multiple Doses (an Open-label, Randomised, Multiple-dose, Crossover Trial)

Conditions
HealthyObesityOverweight
Other Study IDs
  • 1404-0066
  • U1111-1323-8960 (Registry Identifier) (WHO - International Clinical Trials Registry Platform (ICTRP))
NCT ID Number
NCT07407348
Start Date (Actual)
2026-02-26
Last Update Posted
2026-03-17
Completion Date (Estimated)
2027-03-02
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalFormulation A, then Formulation B6
Formulation A
Formulation A of survodutide
Formulation B6
Formulation B6 of survodutide
ExperimentalFormulation B6, then Formulation A
Formulation A
Formulation A of survodutide
Formulation B6
Formulation B6 of survodutide
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

  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

  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 exclusion criteria apply.
Boehringer Ingelheim logoBoehringer Ingelheim
Study Central Contact
Contact: Boehringer Ingelheim, 1-800-243-0127, [email protected]
1 Study Locations in 1 Countries
Quotient Sciences, Nottingham, NG11 6JS, United Kingdom
Boehringer Ingelheim, Contact, 08000514022, [email protected]
Recruiting