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OpenTrials
Completed

NCT Number: NCT04447261

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI 1356225

Drug

BI 1356225

Placebo

Drug

Placebo

Primary outcomes

  1. The percentage of subjects with drug-related adverse events

    Time frame: Up to 40 days

Secondary outcomes

  1. 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

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

    Time frame: Up to 35 days

  3. 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

  4. 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

  5. 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

  6. 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

  7. Cmax (maximum measured concentration of midazolam in plasma)

    Time frame: Up to 35 days

  8. Cmax (maximum measured concentration of celecoxib in plasma)

    Time frame: Up to 35 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1356225 (Randomised, Placebo-controlled, Blinded Within Dose Groups) and Evaluation of Midazolam and Celecoxib Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Patients With Overweight or Obesity

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2020
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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