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Clinical Trials/NL-OMON56752
NL-OMON56752Not yet recruitingNot Applicable

Open-label, randomised, 4 parallel-group, Phase I clinical trial to investigate BI 456906 occupancy of Glucagon receptors in liver and Glucagon-like Peptide 1 receptors in pancreas in comparison with semaglutide after administration of radiolabeled tracer in male and female subjects with obesity using PET and MRI - 1404-0047

Boehringer Ingelheim0 sites30 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 64 (—)

Inclusion Criteria

  • •1. Healthy male or female subjects according to the assessment of the
  • •investigator, as based on a complete medical history including a physical
  • •examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
  • •2. Age of 18 to 65 years (inclusive)
  • •3. BMI of >=30 and <=40 kg/m2 and body weight >=70 kg and <=150 kg.
  • •4. Signed and dated written informed consent prior to admission to the study,
  • •in accordance with GCP and local legislation
  • •5. Women of childbearing potential (WOCBP) 1 must be willing and able to use
  • •two forms of effective contraception where at least one form is a highly
  • •effective method of birth control per ICH M3 (R2) that result in a low failure
  • •rate of less than 1% per year when used consistently and correctly. A list of
  • •contraception methods meeting these criteria is provided in the subject
  • •information (Section 4.2.2.3).

Exclusion Criteria

  • •Subjects will not be allowed to participate if any of the following general
  • •criteria apply:
  • •1. Any finding in the medical examination (including BP, PR or ECG) deviating
  • •from normal and assessed as clinically relevant by the investigator
  • •2. Resting heart rate >100 beats per minute (bpm) and/or systolic blood
  • •pressure >=160 mmHg and/or diastolic blood pressure >=95 mmHg at screening
  • •3. Any laboratory value outside the reference range that the investigator
  • •considers to be of clinical relevance. Subjects with the following abnormal
  • •values are not eligible for the trial participation:
  • •- LDL >160 mg/dL (4.15 mmol/L)
  • •- total cholesterol >240 mg/dL (6.22 mmol/L)
  • •- triglyceride >200 mg/dL (2.26 mmol/L)
  • •- blood glucose >126 mg/dl (7 mmol/L) fasting and/or HbA1c >6.5%
  • •4. Any evidence of a concomitant disease assessed as clinically relevant by the
  • •investigator. Subjects with type 1 and type 2 diabetes mellitus are not
  • •eligible for the trial
  • •5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
  • •immunological or hormonal disorders assessed as clinically relevant by the
  • •investigator
  • •6. Diseases of the central nervous system (including but not limited to any
  • •kind of seizures), and other relevant neurological or psychiatric disorders
  • •7. History of relevant orthostatic hypotension, fainting spells, or blackouts
  • •8. Personal or family history of medullary thyroid carcinoma or multiple
  • •endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit
  • •9. Calcitonin >=100 pg/mL (29.26 pmol/L) at screening
  • •10. Any suicidal behaviour or history of major depressive disorder requiring
  • •inpatient treatment or escalation of care in the past 2 years before
  • •randomization, any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3
  • •months prior to Visit 1
  • •11. Chronic or relevant acute infections
  • •12. History of chronic or acute pancreatitis or elevation of serum
  • •lipase/amylase >2x ULN
  • •13. History of relevant allergy or hypersensitivity (including allergy to the
  • •trial medication or its excipients) according to investigator's assessment
  • •14. Use of prescription or over-the counter drugs within 30 days of planned
  • •administration of trial medication that might reasonably influence the results
  • •of the trial including drugs known to significantly prolong the QT/QTcF
  • •interval; please refer to Section 4.2.2
  • •15. Intake of an investigational drug in another clinical trial within 60 d of
  • •planned administration of investigational drug in the current trial, or
  • •concurrent participation in another clinical trial in which investigational
  • •drug is administered
  • •16. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day) and
  • •inability to refrain from smoking on specified trial days
  • •17. Ongoing chronic alcohol use or drug abuse other than the ones described in
  • •Table 5.2.3: 2, that in the investigator*s opinion, makes the subject an
  • •unreliable trial subject or unlikely to complete the trial
  • •18. Blood donation of more than 500 mL within 30 d of planned administration of
  • •trial medication or intended blood donation during the trial
  • •19. Intention to perform excessive physical activities within one week prior to
  • +3 more not shown

Investigators

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