A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women Who Are Overweight or Obese.

  • STATUS
    Recruiting
  • participants needed
    88
  • sponsor
    Boehringer Ingelheim
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Updated on 5 August 2020
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body mass index
overweight and obesity

Summary

The primary objective of this trial is to investigate safety and tolerability of BI 1356225 in male and female patients with overweight and obesity following oral administration of multiple rising doses per day over 28 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225 will be evaluated

Details
Condition Obesity, Obesity
Age 18years - 70years
Treatment Placebo, BI 1356225
Clinical Study IdentifierNCT04447261
SponsorBoehringer Ingelheim
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male and female patients, age 18 and < 70
Body Mass Index 27 kg/m2 and < 40 kg/m2 at screening
Stable body weight (defined as no more than 5% change) within 3 months prior to screening
further inclusion criteria apply

Exclusion Criteria

Females of childbearing potential
Clinically relevant concomitant disease per investigator judgment
Any condition or disease requiring permanent pharmacotherapy during the trial
Any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months
further exclusion criteria apply
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