A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight

Boehringer Ingelheim87 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obesity

Interventions

BI 1356225DRUG

BI 1356225

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, Germany

Outcomes

Primary Outcomes

The percentage of subjects with drug-related adverse events

Time frame: Up to 40 days

Secondary Outcomes

AUCτ, 1 (area under the concentration-time curve of BI 1356225 in plasma over a uniform dosing interval τ after administration of the first dose)

Time frame: Up to 35 days

Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)

Time frame: Up to 35 days

AUCτ,ss (area under the concentration-time curve of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)

Time frame: Up to 35 days

Cmax,ss (maximum measured concentration of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)

Time frame: Up to 35 days

AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)

Time frame: Up to 35 days

AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point)

Time frame: Up to 35 days

Cmax (maximum measured concentration of midazolam in plasma)

Time frame: Up to 35 days

Cmax (maximum measured concentration of celecoxib in plasma)

Time frame: Up to 35 days

Data from ClinicalTrials.gov

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