Status:
COMPLETED
A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 dos...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04447261
Start Date
June 30 2020
End Date
April 25 2021
Last Update
May 19 2021
Active Locations (1)
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1
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany, 68167