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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-04-25

Brief Summary

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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

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BI 1356225

Group Type EXPERIMENTAL

BI 1356225

Intervention Type DRUG

BI 1356225

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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BI 1356225

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No